Occlusion detection for a fluid infusion device

ABSTRACT

A device for delivering fluid to a user includes a housing, a drive motor assembly in the housing, a force sensor, and an electronics module. The drive motor assembly regulates delivery of fluid by actuating a piston of a fluid reservoir, and the force sensor generates output levels in response to force imparted thereto during, for example, fluid delivery operations. The electronics module processes the output levels of the force sensor to assess the operating health of the force sensor, to check for occlusions in the fluid delivery path, and to monitor the seating status of the fluid reservoir.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/976,591, filed Dec. 22, 2010, and a continuation-in-part ofU.S. patent application Ser. No. 12/976,619, filed Dec. 22, 2010.

TECHNICAL FIELD

Embodiments of the subject matter described herein relate generally tomedical devices. More particularly, embodiments of the subject matterrelate to fluid infusion devices such as personal insulin infusionpumps.

BACKGROUND

Portable medical devices are useful for patients that have conditionsthat must be monitored on a continuous or frequent basis. For example,diabetics are usually required to modify and monitor their dailylifestyle to keep their blood glucose (BG) in balance. Individuals withType 1 diabetes and some individuals with Type 2 diabetes use insulin tocontrol their BG levels. To do so, diabetics routinely keep strictschedules, including ingesting timely nutritious meals, partaking inexercise, monitoring BG levels daily, and adjusting and administeringinsulin dosages accordingly.

The prior art includes a number of fluid infusion devices and insulinpump systems that are designed to deliver accurate and measured doses ofinsulin via infusion sets (an infusion set delivers the insulin througha small diameter tube that terminates at, e.g., a cannula inserted underthe patient's skin). In lieu of a syringe, the patient can simplyactivate the insulin pump to administer an insulin bolus as needed, forexample, in response to the patient's high BG level.

A typical infusion pump includes a housing, which encloses a pump drivesystem, a fluid containment assembly, an electronics system, and a powersupply. The pump drive system typically includes a small motor (DC,stepper, solenoid, or other varieties) and drive train components suchas gears, screws, and levers that convert rotational motor motion to atranslational displacement of a stopper in a reservoir. The fluidcontainment assembly typically includes the reservoir with the stopper,tubing, and a catheter or infusion set to create a fluid path forcarrying medication from the reservoir to the body of a user. Theelectronics system regulates power from the power supply to the motor.The electronics system may include programmable controls to operate themotor continuously or at periodic intervals to obtain a closelycontrolled and accurate delivery of the medication over an extendedperiod.

Some fluid infusion devices use sensors and alarm features designed todetect and indicate certain operating conditions, such as non-deliveryof the medication to the patient due to a fluid path occlusion. In thisregard, a force sensor can be used in a fluid infusion device to detectwhen the force applied to the fluid reservoir stopper reaches a setpoint. The force sensor in such a fluid infusion device could bepositioned at the end of the drive motor assembly that actuates arotatable lead screw, which in turn advances the stopper of thereservoir. With such an arrangement, the force applied to the forcesensor by the drive motor assembly is proportional to the pressureapplied to the medication as a result of power supplied to the drivesystem to advance the stopper. Thus, when a certain force threshold (aset point corresponding to an occlusion condition) is reached, the fluidinfusion device is triggered to generate an alarm to warn the user.

Early detection of an occlusion condition is helpful, because anocclusion can result in “under-dosing,” particularly if the drive systemcontinues to receive commands to deliver medication when the fluid pathis blocked. Accordingly, proper operation of the force sensor isimportant for purposes of occlusion detection, and it is desirable tohave some diagnostic capability related to the health of the forcesensor.

Existing force-based occlusion detection techniques typically rely on afixed threshold or set point that is indicative of an occlusioncondition. A threshold value is selected based on system tolerances. Toavoid frequent false alarms, however, it is necessary to set thethreshold value above the maximum expected force, based on theinteracting system components. Because the threshold value is set at themaximum expected force, if a patient has a particular pump system with anominal delivery force, it may take slightly longer to reach thethreshold force. Accordingly, it is desirable to have an occlusiondetection technique that does not solely rely on a fixed occlusiondetection threshold force.

Some fluid infusion devices use replaceable fluid reservoirs that aresecured in the housing of the device and actuated by a drive assembly.One form of infusion pump utilizes a threaded cap to seat and secure thefluid reservoir in the housing of the pump. The user unscrews thethreaded cap to remove an empty reservoir, replaces the old reservoirwith a new reservoir, and reinstalls the threaded cap to secure the newreservoir in place. During use, the threaded cap might be dislodged(especially if the fluid infusion device is a portable unit that is wornby the patient), resulting in an unseated or improperly installedreservoir. For example, if the user participates in certain physicalactivities (e.g., sports, hiking, or rigorous exercise), then the capmight be unintentionally loosened by physical rotation. As anotherexample, if the user is in a crowded environment (e.g., a concert, anightclub, or a full elevator), then the cap might be inadvertentlyunscrewed through contact with another person or an object. For thisreason, it is desirable to have a reservoir presence and/or seatingdetection technique for a fluid infusion pump.

BRIEF SUMMARY

A method of operating a fluid infusion device is provided. The fluidinfusion device includes a drive motor assembly and a force sensorassociated with the drive motor assembly. The method activates a rewindoperation of the drive motor assembly and determines a rewind forceimparted to the force sensor during the rewind operation. The methodinitiates corrective action for the fluid infusion device when therewind force is less than a lower threshold force or greater than anupper threshold force.

Also provided is an exemplary embodiment of a device for deliveringfluid to a user. The device includes: a housing; a drive motor assemblyin the housing to regulate delivery of fluid by actuating a piston of afluid reservoir; a force sensor associated with the drive motor assemblyto generate output levels in response to force imparted thereto; and anelectronics module coupled to the force sensor to process the outputlevels to determine operating health of the force sensor.

Another embodiment of a method of operating a fluid infusion device isalso provided. The fluid infusion device includes a drive motor assemblyand a force sensor associated with the drive motor assembly. The methodinvolves determining a measure of actuation force imparted to the forcesensor during a fluid delivery action of the drive motor assembly, andcomparing the measure of actuation force against a range of valid valuesthat represents normally expected measures of actuation forces. When themeasure of actuation force is outside the range of valid values, themethod initiates corrective action for the fluid infusion device.

A method of determining a seating status of a fluid reservoir in thereservoir cavity of a fluid infusion device is also provided. The fluidinfusion device includes a drive motor assembly, a force sensorassociated with the drive motor assembly, and a reservoir cavity thataccommodates fluid reservoirs. The method begins by confirming initialseating of the fluid reservoir in the reservoir cavity. The methodcontinues by determining a measure of actuation force imparted to theforce sensor during a fluid delivery action of the drive motor assembly,and comparing the measure of actuation force to an amount of force thatis less than normally expected actuation forces of the fluid infusiondevice, where the amount of force is indicative of an unseated state ofthe fluid reservoir. The method continues by initiating correctiveaction for the fluid infusion device when the measure of actuation forceis less than the amount of force.

A device for delivering fluid to a user is also provided. The deviceincludes: a housing; a reservoir cavity within the housing toaccommodate fluid reservoirs; a drive motor assembly in the housing toregulate delivery of fluid by actuating a piston of a fluid reservoir; aforce sensor associated with the drive motor assembly to generate outputlevels in response to force imparted thereto; and an electronics modulecoupled to the force sensor to process the output levels to determine aseating status of the fluid reservoir in the reservoir cavity.

Another embodiment of a method of determining a seating status of afluid reservoir in the reservoir cavity of a fluid infusion device isprovided. The method obtains baseline actuation force imparted to aforce sensor, after initial seating and priming of the fluid reservoir.The method continues by determining a measured actuation force impartedto the force sensor, the measured actuation force corresponding to adesignated delivery stroke of the drive motor assembly. The method alsogenerates indicia of an unseated reservoir condition when the measuredactuation force is less than the baseline actuation force by at least apredetermined amount of force.

Also provided is a method of determining a seating status of a fluidreservoir in a fluid infusion device having a drive motor assembly thatactuates the fluid reservoir using discrete delivery pulses. The methodobtains measures of actuation force imparted to the force sensor for anumber of consecutive fluid delivery pulses, and calculates apulse-to-pulse difference between consecutive fluid delivery pulses, thepulse-to-pulse difference based on respective measures of actuationforce for the consecutive fluid delivery pulses. The method continues byinitiating corrective action for the fluid infusion device when thepulse-to-pulse difference is greater than a threshold force value.

Another embodiment of a method of determining a seating status of afluid reservoir in a fluid infusion device is provided. The infusiondevice has a drive motor assembly that actuates the fluid reservoirusing discrete delivery pulses, and the method involves: maintaining acount that is indicative of the seating status; storing an adaptivereference force value that corresponds to a previously recorded measureof actuation force imparted to the force sensor during a previous fluiddelivery pulse; obtaining a current measure of actuation force impartedto the force sensor for a current fluid delivery pulse; changing thecount when the current measure of actuation force is less than thedifference between the adaptive reference force value and a thresholdforce value, resulting in an updated count; and generating a seatingstatus alert when the updated count satisfies predetermined alertcriteria.

An exemplary embodiment of a fluid infusion device includes a drivemotor assembly and a force sensor associated with the drive motorassembly. A method of detecting occlusions in a fluid path of the fluidinfusion device determines a plurality of force measurements for a fluiddelivery action of the drive motor assembly, the plurality of forcemeasurements indicating measures of actuation force imparted to theforce sensor for the fluid delivery action. The method continues bydetermining a plurality of quantity measurements for the fluid deliveryaction, each of the plurality of quantity measurements being determinedrelative to a reference quantity measurement. An occlusion is indicatedwhen a first slope of force-versus-quantity for a large sample of theplurality of quantity measurements is greater than or equal to a firstthreshold slope value. An occlusion is also indicated when: (a) a secondslope of force-versus-quantity for a small sample of the plurality ofquantity measurements is greater than or equal to a second thresholdslope value; and (b) a current one of the plurality of forcemeasurements is greater than or equal to a threshold force value.

An exemplary embodiment of a method of detecting occlusions in a fluidpath of a fluid infusion device is also provided. The fluid infusiondevice has a drive motor assembly that actuates a piston of a fluidreservoir to deliver fluid from the fluid reservoir. The method beginsby initiating a fluid delivery action to deliver an amount of fluid fromthe fluid reservoir. The method continues by determining, for each of aplurality of measurement points associated with the fluid deliveryaction, a respective measurement of a quantity that is indicative ofpressure in the fluid path, along with a respective delivered volumemeasurement relative to a reference volume measurement. A first slope iscalculated based upon a current measurement of the quantity, a previousmeasurement of the quantity, a current delivered volume measurementcorresponding to the current measurement of the quantity, and a previousdelivered volume measurement corresponding to the previous measurementof the quantity. A second slope is calculated based upon the currentmeasurement of the quantity, an intervening measurement of the quantitythat is determined after determining the previous measurement of thequantity, the current delivered volume measurement, and an interveningdelivered volume measurement corresponding to the interveningmeasurement of the quantity. The method continues by indicating whetheran occlusion has occurred by using the first slope and the second slope.

Also provided is an exemplary embodiment of a method of detectingocclusions in a fluid path of a fluid infusion device having a drivemotor assembly that actuates a fluid reservoir by applying actuationforce to a piston of the fluid reservoir. The method involves initiatinga fluid delivery action intended to deliver an amount of fluid from thefluid reservoir, and determining measures of fluid pressure in the fluidpath for the fluid delivery action. The method indicates an occlusionwhen a first rate of change of the measures of fluid pressure is greaterthan or equal to first threshold value, the first rate of change basedupon a first measurement window. The method also indicates an occlusionwhen: (a) a second rate of change of the measures of fluid pressure isgreater than or equal to a second threshold value, the second rate ofchange based upon a second measurement window; and (b) a current measureof fluid pressure is greater than or equal to a threshold force value.

A device for delivering fluid to a user is also provided. The deviceincludes a housing, a reservoir cavity within the housing to accommodatefluid reservoirs, a drive motor assembly in the housing to regulatedelivery of fluid by actuating a piston of a fluid reservoir, a forcesensor associated with the drive motor assembly to generate outputlevels in response to force imparted thereto, and an electronics modulecoupled to the force sensor. The electronics module processes the outputlevels to detect occlusions in a fluid path of the device for a fluiddelivery action.

This summary is provided to introduce a selection of concepts in asimplified form that are further described below in the detaileddescription. This summary is not intended to identify key features oressential features of the claimed subject matter, nor is it intended tobe used as an aid in determining the scope of the claimed subjectmatter.

BRIEF DESCRIPTION OF THE DRAWINGS

A more complete understanding of the subject matter may be derived byreferring to the detailed description and claims when considered inconjunction with the following figures, wherein like reference numbersrefer to similar elements throughout the figures.

FIG. 1 is a schematic representation of an embodiment of a fluidinfusion device;

FIG. 2 is an exploded perspective view of the fluid infusion deviceshown in FIG. 1;

FIG. 3 is a cross sectional view of the fluid infusion device shown inFIG. 1, corresponding to a cross section taken longitudinally throughthe drive motor assembly and the fluid reservoir;

FIG. 4 is a schematic block diagram representation of an embodiment of afluid infusion device;

FIG. 5 is a flow chart that illustrates an embodiment of a processassociated with the operation of a fluid infusion device;

FIG. 6 is a flow chart that illustrates an embodiment of a rewind forcecalibration process for a fluid infusion device;

FIG. 7 is a flow chart that illustrates another embodiment of a processassociated with the operation of a fluid infusion device;

FIG. 8 is a flow chart that illustrates an embodiment of a process thatchecks the seating status of a fluid reservoir of a fluid infusiondevice;

FIG. 9 is a flow chart that illustrates another embodiment of a processthat checks the seating status of a fluid reservoir of a fluid infusiondevice;

FIG. 10 is a flow chart that illustrates yet another embodiment of aprocess that checks the seating status of a fluid reservoir of a fluidinfusion device;

FIG. 11 is a graph that illustrates measures of actuation forces for aproperly seated fluid reservoir;

FIG. 12 is a graph that illustrates measures of actuation forces for afluid reservoir that becomes unseated;

FIG. 13 is a flow chart that illustrates an embodiment of an occlusiondetection process for a fluid infusion device;

FIG. 14 is a flow chart that illustrates an exemplary embodiment of amulti-mode occlusion detection process;

FIG. 15 is a graph that depicts an exemplary plot of fluid reservoiractuation force versus volume of fluid delivered from a fluid infusiondevice; and

FIG. 16 is a flow chart that illustrates another exemplary embodiment ofa multi-mode occlusion detection process.

DETAILED DESCRIPTION

The following detailed description is merely illustrative in nature andis not intended to limit the embodiments of the subject matter or theapplication and uses of such embodiments. As used herein, the word“exemplary” means “serving as an example, instance, or illustration.”Any implementation described herein as exemplary is not necessarily tobe construed as preferred or advantageous over other implementations.Furthermore, there is no intention to be bound by any expressed orimplied theory presented in the preceding technical field, background,brief summary or the following detailed description.

Techniques and technologies may be described herein in terms offunctional and/or logical block components, and with reference tosymbolic representations of operations, processing tasks, and functionsthat may be performed by various computing components or devices. Itshould be appreciated that the various block components shown in thefigures may be realized by any number of hardware, software, and/orfirmware components configured to perform the specified functions. Forexample, an embodiment of a system or a component may employ variousintegrated circuit components, e.g., memory elements, digital signalprocessing elements, logic elements, look-up tables, or the like, whichmay carry out a variety of functions under the control of one or moremicroprocessors or other control devices.

For the sake of brevity, conventional techniques related to infusionsystem operation, insulin pump and/or infusion set operation, bloodglucose sensing and monitoring, force sensors, signal processing, andother functional aspects of the systems (and the individual operatingcomponents of the systems) may not be described in detail here. Examplesof infusion pumps and/or related pump drive systems used to administerinsulin and other medications may be of the type described in, but notlimited to, U.S. Pat. Nos. 4,562,751; 4,678,408; 4,685,903; 5,080,653;5,505,709; 5,097,122; 6,485,465; 6,554,798; 6,558,351; 6,659,980;6,752,787; 6,817,990; 6,932,584; and 7,621,893; which are hereinincorporated by reference.

The subject matter described here relates to a fluid infusion device ofthe type used to treat a medical condition of a patient. The infusiondevice is used for infusing fluid into the body of a user. Thenon-limiting examples described below relate to a medical device used totreat diabetes (more specifically, an insulin pump), althoughembodiments of the disclosed subject matter are not so limited.Accordingly, the infused fluid is insulin in certain embodiments. Inalternative embodiments, however, many other fluids may be administeredthrough infusion such as, but not limited to, disease treatments, drugsto treat pulmonary hypertension, iron chelation drugs, pain medications,anti-cancer treatments, medications, vitamins, hormones, or the like.

A methodology for monitoring the operational health of a sensor (e.g., aforce sensor) is implemented by an exemplary embodiment of a fluidinfusion device. The fluid infusion device monitors force measurementsobtained from the force sensor during a motor rewind operation todetermine whether or not the force sensor might be out of calibration,on the verge of failure, or the like. The force normally experienced bythe force sensor during rewind operations should be zero or close tozero, due to the absence of a fluid reservoir in the fluid infusiondevice, and because the fluid infusion device is driving in rewind mode,i.e., away from the plunger of the fluid reservoir. Accordingly, thefluid infusion device can assume that a properly functioning forcesensor will produce rewind force readings in the neighborhood of zero orclose to zero. Thus, if a rewind force measurement significantlydeviates from the assumed baseline value (or range of values), then thefluid infusion device can take appropriate corrective action.

Another methodology for monitoring the operational health of a forcesensor obtains force readings during a fluid delivery operation andcompares the force readings to determine whether or not the force sensoris operating as expected. This alternate methodology measures the forcesassociated with individual fluid delivery strokes or drive motor pulses.Under normal and typical operating conditions, these forces will berelatively stable during one fluid delivery operation, and the variationfrom one stroke to another will be slight (absent an external impact orshock suffered by the fluid infusion device). Thus, if the force sensorreading is out of the expected operating range during a fluid deliveryoperation, the fluid infusion device can take appropriate correctiveaction. For example, if the force sensor output during fluid deliveryhappens to be −0.5 pounds, then clearly there is a problem because inreality the measured force should not be a negative value.

A fluid infusion device may also have an occlusion detection featurethat determines when the fluid delivery path is occluded. Occlusiondetection techniques are usually based on sensor measurements (force,pressure, stress) that are influenced by the flow status of the fluiddelivery path. An exemplary embodiment of a fluid infusion device asdescribed here employs an adaptive occlusion detection technique thatneed not rely on a fixed occlusion detection force threshold. Instead,the adaptive occlusion detection technique evaluates the rate of changeof a metric associated with force variations per units of fluid to bedelivered. For example, the typical force variation for a fluidreservoir might result in a variation of about ±X pounds per unit (lb/U)over a set number of delivery strokes (or drive motor pulses). If,however, the fluid infusion device detects a significant increase inthis metric during a fluid delivery operation (e.g., ±Y lb/U, where Y issignificantly larger than X) over the same set number of deliverystrokes, then the fluid infusion device can take appropriate correctiveaction. The values of X and Y can also be in units of lb/pulse or thelike. An example of a corrective action might be, but not limited to,immediately indicate or warn of an occlusion or simply lower the setthreshold value by a set constant or percentage and allow the pump tocontinue delivery for a set number of pulses or units to see if the pumprecovers (recovery might occur in the case of a kinked cannula). Theadaptive occlusion detection methodology allows the fluid infusiondevice to determine the existence of an occlusion much quicker, relativeto a fixed threshold based methodology. Quicker occlusion detection ismade possible because the fluid infusion device need not be operateduntil a high threshold force is reached; rather, occlusion can bedetected earlier without having to wait for a high force condition.

An exemplary embodiment of a fluid infusion device may also beconfigured to determine whether or not a fluid reservoir is properlyseated and installed. The presence (or lack thereof) of the fluidreservoir is determined based upon force sensor readings that areobtained after proper initial installation and seating of the fluidreservoir. In accordance with one embodiment, one or more forcethresholds are used to determine whether or not the fluid reservoir isproperly seated. If a measured force does not satisfy a force thresholdthat is indicative of proper reservoir seating, then the fluid infusiondevice can take corrective action. In accordance with another exemplaryembodiment, the fluid infusion device measures and processes the forcesassociated with individual fluid delivery strokes or drive motor pulsesto determine when the fluid reservoir has been dislodged, removed, orunseated.

FIG. 1 is a plan view of an exemplary embodiment of a fluid infusiondevice 100. FIG. 1 also shows an infusion set 102 coupled to the fluidinfusion device 100. The fluid infusion device 100 is designed to becarried or worn by the patient. The fluid infusion device 100 mayleverage a number of conventional features, components, elements, andcharacteristics of existing fluid infusion devices. For example, thefluid infusion device 100 may incorporate some of the features,components, elements, and/or characteristics described in U.S. Pat. Nos.6,485,465 and 7,621,893, the relevant content of which is incorporatedby reference herein.

This embodiment shown in FIG. 1 includes a user interface 104 thatincludes several buttons that can be activated by the user. Thesebuttons can be used to administer a bolus of insulin, to change therapysettings, to change user preferences, to select display features, andthe like. Although not required, the illustrated embodiment of the fluidinfusion device 100 includes a display element 106. The display element106 can be used to present various types of information or data to theuser, such as, without limitation: the current glucose level of thepatient; the time; a graph or chart of the patient's glucose levelversus time; device status indicators; etc. In some embodiments, thedisplay element 106 is realized as a touch screen display element and,therefore, the display element 106 also serves as a user interfacecomponent.

The fluid infusion device 100 accommodates a fluid reservoir (hiddenfrom view in FIG. 1) for the fluid to be delivered to the user. A lengthof tubing 108 is the flow path that couples the fluid reservoir to theinfusion set 102. The tubing 108 extends from the fluid infusion device100 to the infusion set 102, which provides a fluid pathway with thebody of the user. A removable cap or fitting 110 is suitably sized andconfigured to accommodate replacement of fluid reservoirs (which aretypically disposable) as needed. In this regard, the fitting 110 isdesigned to accommodate the fluid path from the fluid reservoir to thetubing 108.

FIG. 2 is an exploded perspective view of the fluid infusion device 100.For the sake of brevity and simplicity, FIG. 2 is a simplified depictionof the fluid infusion device 100 that does not include all of theelements, components, and features that would otherwise be present in atypical embodiment. It should be appreciated that a deployedimplementation of the fluid infusion device 100 will include additionalfeatures, components, and elements that are not shown in the figures.

The embodiment of the fluid infusion device 100 illustrated in FIG. 2includes a housing 112 and a housing end cap 114 that is coupled to anend 116 of the housing 112 to enclose components within the housing 112.These internal components include, without limitation: a battery tubesubassembly 118; a sleeve 120; a slide 121; an electronics assembly 122;a drive motor assembly 124 having a drive screw 125; a force sensor 126;and a motor support cap 128. FIG. 2 also depicts some components thatare located outside the housing 112, namely, a keypad assembly 130 and agraphic keypad overlay 132 for the keypad assembly 130. The keypadassembly 130 and the graphic keypad overlay 132 may be considered to bepart of the user interface 104 of the fluid infusion device 100. Theouter edge of the motor support cap 128 is attached to the interior sideof the housing 112, and the motor support cap 128 contacts the forcesensor 126 to remove assembly tolerances from the drive motor assembly124. FIG. 2 also depicts an exemplary fluid reservoir 111, which isinserted into a reservoir cavity defined within the housing 112. Thereservoir cavity is configured, sized, and shaped to accommodate fluidreservoirs, and the fluid reservoir 111 is maintained in the reservoircavity using the fitting 110. The electronics assembly 122 may include asuitably configured electronics module (not shown in FIG. 2; see FIG. 4and related description below), which may include or cooperate with apower supply, at least one memory element, at least one processor,processing logic, and device software, firmware, and applicationprograms.

FIG. 3 is a cross sectional view of the fluid infusion device 100,corresponding to a cross section taken longitudinally through the drivemotor assembly 124 and the fluid reservoir 111. FIG. 3 depicts the stateof the fluid infusion device 100 after the fluid reservoir 111 has beeninserted into the reservoir cavity 134 and after the fitting 110 hasbeen secured to the housing 112 to hold the fluid reservoir 111 inplace. While certain embodiments accommodate disposable, prefilledreservoirs, alternative embodiments may use refillable cartridges,syringes or the like. A cartridge can be prefilled with insulin (orother drug or fluid) and inserted into the housing 112. Alternatively, acartridge could be filled by the user using an appropriate adapterand/or any suitable refilling device.

When assembled as shown in FIG. 3, the drive motor assembly 124 islocated in the housing 112. The force sensor 126 is operativelyassociated with the drive motor assembly 124. For this particularembodiment, the force sensor 126 is coupled to the drive motor assembly124, and it is located between a base end of the drive motor assembly124 and the motor support cap 128. In one implementation, the forcesensor 126 is affixed to the base end of the drive motor assembly 124such that the force sensor 126 reacts when it bears against the motorsupport cap 128. In another implementation, the force sensor 126 isaffixed to the housing end cap 114 such that the force sensor 126 reactswhen the drive motor assembly 124 bears against the force sensor 126.This configuration and arrangement of the drive motor assembly 124 andthe force sensor 126 allows the force sensor 126 to react to forcesimparted thereto by the drive motor assembly 124 and/or forces impartedto the drive motor assembly 124 via the fluid pressure of the fluidreservoir 111.

The drive motor assembly 124 includes an electric motor 136 that isactuated and controlled by the electronics module of the fluid infusiondevice 100. The motor 136 is preferably realized as a stepper motor thatrotates in a stepwise or discrete manner corresponding to the desirednumber of fluid delivery strokes. Alternatively, the motor 136 could bea DC motor, a solenoid, or the like. The motor 136 may optionallyinclude an encoder (not shown), which cooperates with the electronicsmodule of the fluid infusion device 100 to monitor the number of motorrotations or portions thereof. This in turn can be used to accuratelydetermine the position of the slide 121, thus providing informationrelating to the amount of fluid dispensed from the fluid reservoir 111.

The drive motor assembly 124 can be mounted in the housing 112 using anappropriate mounting feature, structure, or element. Alternatively, themounting could be accomplished using a shaft bearing and leaf spring orother known compliance mountings.

The illustrated embodiment of the drive motor assembly 124 includes adrive member (such as the externally threaded drive gear or drive screw125) that engages an internally threaded second drive member (such asthe slide 121) having a coupler 142. The coupler 142 may be attached toor integrated with the slide 121, as depicted in FIG. 2 and FIG. 3. Theslide 121 is sized to fit within the housing of the fluid reservoir 111,which enables the slide 121 to operatively cooperate with the fluidreservoir 111. The fluid reservoir 111 includes a plunger or piston 144with at least one sealing element or feature (e.g., one or more O-rings,integral raised ridges, or a washer) for forming a fluid and air tightseal with the inner wall of the fluid reservoir 111. As mentionedpreviously, the fluid reservoir 111 is secured into the housing 112 withthe fitting 110, which also serves as the interface between the fluidreservoir 111 and the infusion set tubing 108. For this embodiment, thepiston 144 is in contact with a linear actuation member, such as theslide 121. For example, the piston 144 may have a female portion 146that receives the coupler 142 carried by the slide 121. The femaleportion 146 is positioned at the end face of the piston 144, and it issized to receive and accommodate the coupler 142. In certainembodiments, the female portion 146 includes a threaded cavity thatengages external threads of the coupler 142.

Referring to FIG. 3, rotation of the drive shaft of the motor 136results in corresponding rotation of the drive screw 125, which in turndrives the slide 121 via the threaded engagement. Thus, rotation of thedrive screw 125 results in axial displacement of the slide 121 and,therefore, axial displacement of the coupler 142. Such displacement ofthe coupler 142 moves the piston 144 (upward in FIG. 3) to deliver apredetermined or commanded amount of medication or liquid from the fluidinfusion device 100. In this manner, the drive motor assembly 124 isconfigured to regulate delivery of fluid by actuating the piston 144(under the control of the electronics module and/or control system ofthe fluid infusion device 100). As described above, if a stepper motoris employed, then the drive motor assembly 124 can regulate delivery offluid from the fluid infusion device 100 in discrete actuation ordelivery strokes. The fluid infusion device 100 can employ the sleeve120 or an equivalent feature (such as an anti-rotation key) to inhibitrotation of the drive motor assembly 124, which might otherwise resultfrom torque generated by the motor 136. In some embodiments, the driveshaft of the drive motor assembly 124, the drive screw 125, and theslide 121 are all coaxially centered within the longitudinal axis oftravel of the piston 144. In certain alternative embodiments, one ormore of these components may be offset from the center of the axis oftravel and yet remain aligned with the axis of travel, which extendsalong the length of the fluid reservoir 111.

As mentioned above, certain embodiments of the fluid infusion device 100accommodate removable and replaceable fluid reservoirs. When the slide121 and, therefore, the piston 144 of the fluid reservoir 111 are intheir fully extended positions, the piston 144 has forced most, if notall, of the fluid out of the fluid reservoir 111. After the piston 144has reached the end of its travel path, indicating that the fluidreservoir 111 has been depleted, the fluid reservoir 111 may be removedsuch that the female portion 146 of the piston 144 disengages from thecoupler 142 of the slide 121. After the empty (or otherwise used) fluidreservoir 111 is removed, the electronics module or control system ofthe fluid infusion device 100 initiates a rewind operation during whichthe motor 136 rotates in the reverse direction to rewind the slide 121back to its fully retracted position. Thereafter, a new or refilledfluid reservoir 111 can be installed, seated, and primed for use. Inthis regard, an embodiment provides for advancement of the slide 121upon the insertion of a fluid reservoir 111 into the housing 112. Theslide 121 advances until its coupler 142 comes into contact with thepiston 144 of the fluid reservoir 111. In alternative embodiments havinga threaded piston engagement, the slide 121 advances until the threadsof the coupler 142 engage the threads in the female portion 146 of thepiston 144. When the threads engage in this fashion, they need not do soby twisting. Rather, they may ratchet over one another. In operation,the force sensor 126 may be used to determine when the slide 121contacts the piston 144, when the coupler 142 is properly seated in thefemale portion 146, and/or when the fluid reservoir 111 has been primedand is ready to deliver measured doses of fluid.

Although the illustrated embodiment employs a coaxial or inline drivesystem, alternative configurations could be utilized. For example, adrive system that uses a lead screw, a drive nut, and actuation arms (ofthe type described in U.S. Pat. No. 6,485,465) may be employed, with theforce sensor 126 positioned in an appropriate location. In variousembodiments, the drive train might include one or more lead screws,cams, ratchets, jacks, pulleys, pawls, clamps, gears, nuts, slides,bearings, levers, beams, stoppers, plungers, sliders, brackets, guides,bearings, supports, bellows, caps, diaphragms, bags, heaters, or thelike. Moreover, although the illustrated embodiment employs a sensorpositioned at the end of the fluid drive train, other arrangements couldbe deployed. For example, a sensor could be placed at or near the frontend of the fluid drive train.

In particular embodiments, the force sensor 126 is used to detect whenthe slide 121 contacts the piston 144. Thus, after the fluid reservoir111 is placed into the fluid infusion device 100, the motor 136 isactivated to move the slide 121 toward the fluid reservoir 111 to engagethe piston 144. In this regard, when a shoulder region 150 (see FIG. 3)of the slide 121 first contacts the piston 144, the electronics moduledetects an increase in force imparted to the force sensor 126. Themeasured force continues to increase as the motor 136 continues to driveforward, in response to the fluid resistance in the fluid reservoir 111.When the slide 121 is properly seated with the piston 144, the measuredforce increases to the seating threshold level. During the seatingoperation, if the measured force exceeds this seating threshold, themotor 136 is stopped until further commands are issued. The seatingthreshold is generally about 1.5 pounds. In alternative embodiments,higher or lower seating thresholds may be used depending on the forcerequired to mate the slide 121 with the piston 144, the force requiredto urge fluid from the fluid reservoir 111, the speed of the motor 136,the accuracy and resolution of the force sensor 126, or the like.

It should be appreciated that other force thresholds can be used forother purposes. During priming of fluid reservoirs, for example, athreshold of about 4.0 pounds is used. In some embodiments, levelsgreater than about 5.0 pounds are used to detect shock loads that may bedamaging to the fluid infusion device 100.

The force sensor 126 is configured to react in response to forceimparted thereto. In this regard, electrical, mechanical, magnetic,and/or other measurable or detectable characteristics of the forcesensor 126 vary in accordance with the amount of force applied to theforce sensor 126. In practice, the force sensor 126 might implement orotherwise leverage known sensor technologies, such as the sensortechnology described in U.S. Pat. No. 6,485,465. As shown in FIG. 2, theforce sensor 126 includes at least one electrical lead 154 that iselectrically coupled to the electronics module (or controller) of thefluid infusion device 100. Alternatively, the force sensor 126 could usewireless data communication technology to provide force-related data tothe electronics module. In certain implementations, the force sensor 126is suitably configured to indicate or generate a plurality of differentoutput levels that can be monitored and/or determined by the electronicsmodule. In practice, the output levels obtained from the force sensor126 are initially conveyed as analog voltages or analog currents, andthe electronics module includes an analog-to-digital converter thattransforms a sampled analog voltage into a digital representation.Conversion of sensor voltage into the digital domain is desirable forease of processing, comparison to threshold values, and the like.

In particular embodiments, the force sensor 126 is realized as anelectromechanical component having at least one variable resistance thatchanges as the force applied to the force sensor 126 changes. Inalternative embodiments, the force sensor 126 is a capacitive sensor, apiezoresistive sensor, a piezoelectric sensor, a magnetic sensor, anoptical sensor, a potentiometer, a micro-machined sensor, a lineartransducer, an encoder, a strain gauge, or the like, and the detectableparameter or characteristic might be compression, shear, tension,displacement, distance, rotation, torque, force, pressure, or the like.In practice, changing characteristics of the force sensor 126 areassociated with output signal characteristics that are responsive to aphysical parameter to be measured. Moreover, the range and resolution ofthe monitored output signal provides for the desired number of outputlevels (e.g., different states, values, quantities, signals, magnitudes,frequencies, steps, or the like) across the range of measurement. Forexample, the force sensor 126 might generate a low or zero value whenthe applied force is relatively low, a high or maximum value when theapplied force is relatively high, and intermediate values when theapplied force is within the detectable range.

In certain exemplary embodiments, the electronics module of the fluidinfusion device 100 maintains a constant supply voltage across the forcesensor 126, and the monitored output signal of the force sensor 126 is asignal current that passes through a resistive material of the forcesensor 126. Thus, the signal current varies with the amount of forceapplied to the force sensor 126 because the resistance of the forcesensor 126 varies with force and the supply voltage across the forcesensor 126 is constant. The electronics module converts the monitoredsignal current into a signal voltage, which is then used as anindication of the force imparted to the force sensor 126 (which may becaused by the drive motor assembly 124, by fluid pressure in the fluidreservoir 111, by impact experienced by the fluid infusion device 100,etc.). In alternative embodiments, a constant supply current is used andthe signal voltage across the force sensor 126 varies with force (fluidpressure).

In certain embodiments, sensor measurements are taken prior tocommanding the drive system to deliver fluid, and soon after the drivesystem has stopped delivering fluid. In alternative embodiments, sensordata is collected on a continuous basis at a particular sampling rate(for example, 10.0 Hz, 3.0 Hz, once every 10 seconds, once a minute,once every five minutes, or the like). In further alternativeembodiments, the sensor data is only collected prior to commanding thedrive system to deliver fluid. In still further alternative embodiments,sensor data is collected during fluid delivery (during delivery strokesand/or between delivery strokes).

In practice, the force sensor 126 and associated electronics aredesigned to measure forces between about zero pounds and about fivepounds with a desired resolution of about 0.01 pounds. In preferredembodiments, the force sensor 126 and associated electronics provide arelatively linear voltage output in response to forces applied to theforce sensor 126 by one or more drive train components. In alternativeembodiments, the range and resolution of the force sensor 126 might varyfrom that specified above. Furthermore, the sensor range and/orresolution may vary in accordance with the concentration of the fluidbeing delivered, the diameter of the fluid reservoir 111, the diameterof the fluid path, the nominal range of force experienced during normaloperation of the drive motor assembly 124, the amount of sensor noise,the algorithms applied to detect trends from sensor measurements, or thelike. Moreover, the fluid infusion device 100 and the force sensor 126should be suitably configured to survive shock levels that result inmuch higher forces being applied to the force sensor 126 than theintended sensor measurement range.

As mentioned previously, the fluid infusion device 100 is suitablyconfigured to support a number of techniques, processes, andmethodologies that utilize the force sensor 126. In practice, the fluidinfusion device 100 includes an electronics module, processing logic,software applications, and/or other features that are used to carry outthe various operating processes described here. In this regard, FIG. 4is a schematic block diagram representation of an embodiment of thefluid infusion device 100. FIG. 4 depicts some previously-describedelements of the fluid infusion device 100 as functional blocks ormodules, namely, the display element 106; the user interface 104; thedrive motor assembly 124; and the force sensor 126. FIG. 4 also depictsthe fluid reservoir 111 and the infusion set 102 in block format. Thisparticular embodiment of the fluid infusion device 100 also includes,without limitation: a suitable amount of memory 160; an electronicsmodule 162 (which may include or cooperate with one or more processors,processing modules, controllers, state machines, or the like); a powersupply 164 such as a battery or a battery pack; and other infusion pumphardware, software, and applications 166. The elements of the fluidinfusion device 100 may be coupled together via an interconnectionarchitecture 168 or arrangement that facilitates transfer of data,commands, power, etc.

The display element 106 represents the primary graphical interface ofthe fluid infusion device 100. The display element 106 may leverageknown plasma, liquid crystal display (LCD), thin film transistor (TFT),and/or other display technologies. The actual size, resolution, andoperating specifications of the display element 106 can be selected tosuit the needs of the particular application. Notably, the displayelement 106 may include or be realized as a touch screen display elementthat can accommodate touch screen techniques and technologies. Inpractice, the display element 106 may be driven by a suitable displaydriver to enable the fluid infusion device 100 to display physiologicalpatient data, status information, clock information, alarms, alerts,and/or other information and data received or processed by the fluidinfusion device 100.

The user interface 104 may include a variety of items such as, withoutlimitation: a keypad, keys, buttons, a keyboard, switches, knobs (whichmay be rotary or push/rotary), a touchpad, a microphone suitably adaptedto receive voice commands, a joystick, a pointing device, analphanumeric character entry device or touch element, a trackball, amotion sensor, a lever, a slider bar, a virtual writing tablet, or anydevice, component, or function that enables the user to select options,input information, or otherwise control the operation of the fluidinfusion device 100. In this context, the user interface 104 maycooperate with or include a touch screen display element 106. The userinterface 104 allows a user to control the delivery of fluid via theinfusion set 102.

The electronics module 162 may include or be implemented with a generalpurpose processor, a content addressable memory, a digital signalprocessor, an application specific integrated circuit, a fieldprogrammable gate array, any suitable programmable logic device,discrete gate or transistor logic, discrete hardware components, or anycombination designed to perform the functions described here. Aprocessor device may be realized as a microprocessor, a controller, amicrocontroller, or a state machine. Moreover, a processor device may beimplemented as a combination of computing devices, e.g., a combinationof a digital signal processor and a microprocessor, a plurality ofmicroprocessors, one or more microprocessors in conjunction with adigital signal processor core, or any other such configuration.

The electronics module 162 may include one processor device or aplurality of cooperating processor devices. Moreover, a functional orlogical module/component of the fluid infusion device 100 might berealized by, implemented with, and/or controlled by processing logicmaintained by or included with the electronics module 162. For example,the display element 106, the user interface 104, the drive motorassembly 124, and/or the infusion pump hardware, software, andapplications 166 (or portions thereof) may be implemented in orcontrolled by the electronics module 162.

The memory 160 may be realized as RAM memory, flash memory, EPROMmemory, EEPROM memory, registers, a hard disk, a removable disk, aCD-ROM, or any other form of storage medium known in the art. In thisregard, the memory 160 can be coupled to the electronics module 162 suchthat the electronics module 162 can read information from, and writeinformation to, the memory 160. In the alternative, the memory 160 maybe integral to the electronics module 162. As an example, a processor ofthe electronics module 162 and the memory 160 may reside in an ASIC. Inpractice, a functional or logical module/component of the fluid infusiondevice 100 might be realized using program code that is maintained inthe memory 160. Moreover, the memory 160 can be used to store datautilized to support the operation of the fluid infusion device 100,including, without limitation, sensor data, force measurements, forcethresholds, alert/alarm history, and the like (as will become apparentfrom the following description).

The infusion pump hardware, software, and applications 166 are utilizedto carry out fluid infusion features, operations, and functionality.Thus, the infusion pump hardware, software, and applications 166 mayinclude or cooperate with the infusion set 102 and/or the fluidreservoir 111 (as described above). It should be appreciated that theinfusion pump hardware, software, and applications 166 may leverageknown techniques to carry out conventional infusion pump functions andoperations, and such known aspects will not be described in detail here.

A fluid infusion device can support one or more features or operationsthat enhance its fluid infusion functionality and/or enhance the userexperience of the fluid infusion device. The following sections includedescriptions of various processes and methods that may be performed by afluid infusion device. The various tasks performed in connection with agiven process may be performed by software, hardware, firmware, or anycombination thereof. For illustrative purposes, a process might bedescribed with reference to elements mentioned above in connection withFIGS. 1-4. In practice, portions of a given process may be performed bydifferent elements of the described system, e.g., a sensor, a drivemotor assembly, an electronics module, a processor, or the like. Itshould be appreciated that a described process may include any number ofadditional or alternative tasks, the tasks included in a particular flowchart need not be performed in the illustrated order, an embodiment of adescribed process may omit one or more of the illustrated tasks, and agiven process may be incorporated into a more comprehensive procedure orprocess having additional functionality not described in detail herein.

Sensor Health Monitoring

For reasons presented above, the force sensor 126 in the fluid infusiondevice 100 is an important component that, at a minimum, is used todetermine when a new fluid reservoir 111 is seated and when an occlusionhas occurred. During use, the output and/or electromechanicalcharacteristics of the force sensor 126 may drift over time. The driftcan be attributed to the aging of mechanical components, impacts orshocks suffered by the fluid infusion device 100, environmentalexposure, etc. It is desirable to monitor sensor drift so that the fluidinfusion device 100 can alert the patient if the sensor drift exceeds atolerable amount. Notably, the force sensor 126 cannot be easily orconveniently calibrated, for example on a yearly basis, because it isnot accessible. Consequently, the force sensor 126 should not divertfrom a calibration curve (which contemplates typical variations ordrifting of the force sensor 126) over the life of the product.

The sensor health monitoring features of the fluid infusion device 100can be utilized to determine and monitor the drift characteristics ofthe force sensor 126. In accordance with one approach, it is assumedthat the force sensor 126 experiences a consistent and relatively lowload during rewind operations, which are performed before installing anew fluid reservoir 111. During a calibration routine (which may beperformed, for example, during manufacturing of the fluid infusiondevice 100), the device records force data collected during one or morerewind stages. The force data is used to generate a nominal rewind forcevalue, which may represent an average of the collected values, themaximum collected value, the minimum collected value, or the like. Thisrewind force value is saved in the memory 160 of the fluid infusiondevice 100. Thereafter, when deployed and operating, the fluid infusiondevice 100 performs a rewind force average check and compares the valueto the saved rewind force. If the measured rewind force is within aspecified range of the calibration rewind force value, then the fluidinfusion device 100 continues to operate as usual. If, however, themeasured rewind force drifts below a level that is not acceptable, thenthe fluid infusion device 100 can generate an alarm, an alert, orrespond in a predetermined manner. The sensor health can be checkedwhenever a new fluid reservoir 111 is installed, typically every threedays.

FIG. 5 is a flow chart that illustrates an embodiment of a process 200associated with the operation of a fluid infusion device, such as thefluid infusion device 100 described above. The process 200 may beginwith the activation of a rewind operation of the drive motor assembly(task 202). As explained above, the drive motor assembly rewinds afterremoving an old fluid reservoir and before installing a new fluidreservoir. Accordingly, task 202 could be automatically performedwhenever a fluid reservoir is removed from the fluid infusion device. Asanother option, task 202 could be performed (either automatically orinitiated by the user) at other times when the fluid infusion device 100is not delivering fluid. In this regard, the slide 121 can be retractedfrom the piston 144 while leaving the piston 144 in place. The positionof the slide 121 prior to retraction can be stored such that the slide121 can be precisely returned to its former position to continuedelivering fluid. In response to the rewind activation, the process 200rewinds the drive motor assembly by an appropriate amount (task 204). Toaccommodate installation of a new fluid reservoir, task 204 rewinds thedrive motor assembly until the slide is fully retracted.

The absence of a fluid reservoir during the rewind operation results inno loading on the drive motor assembly. For this reason, the process 200determines a rewind force imparted to the force sensor during the rewindoperation (task 206). Task 206 could obtain a single rewind forcemeasurement at any time during the rewind operation, it could calculatean average rewind force based upon any number of rewind forcemeasurements obtained during the rewind operation, or it could generateany rewind force value or metric that is based upon one or moreindividual rewind force measurements obtained during the rewindoperation. For simplicity, this particular embodiment of the process 200assumes that a single rewind force measurement is determined at task206.

The process 200 may continue by comparing the rewind force measurementto one or more threshold forces. For this example, the process 200determines whether or not the rewind force measurement falls within apredetermined range, and initiates corrective action at the fluidinfusion device when the rewind force measurement does not fall withinthat range. Thus, if the rewind force measurement is less than the lowerthreshold force (query task 208), then the fluid infusion deviceinitiates and executes appropriate corrective action (task 210).Similarly, if the rewind force measurement is greater than the upperthreshold force (query task 212), then the fluid infusion deviceinitiates and executes appropriate corrective action (task 214). Thecorrective action taken by the fluid infusion device may include one ormore of the following, without limitation: generating an alert or analarm at the fluid infusion device; stopping or inhibiting fluiddelivery; presenting instructions, a maintenance reminder, or a messageto the user; or the like. In practice, an alert, alarm, or warning mayinclude, without limitation: sounds; one or more synthesized voices;vibrations or other haptic feedback; displayed symbols or messages;lights; transmitted signals; Braille output; or the like. Other forms ofcorrective action include, without limitation: running a self test ofthe fluid infusion device; recalibrating the threshold forces;temporarily disabling the fluid infusion device; or the like.

A rewind force measurement that is less than the lower threshold forceindicates that the measured force is less than the actual force appliedto the force sensor. Consequently, it may be more difficult for thefluid infusion device to accurately and quickly detect the onset of anocclusion in the fluid path based on the force sensor output. On theother hand, a rewind force measurement that is greater than the upperthreshold force indicates that the measured force is greater than theactual force applied to the force sensor. Consequently, the fluidinfusion device might detect the onset of an occlusion too soon, orfalsely detect an occlusion. Therefore, the type of corrective actiontaken at task 210 may be different than the type of corrective actiontaken at task 214. In this regard, different alert characteristics(colors, volume, frequency, sounds), different message content orformats, and/or different combinations of the corrective actionsdescribed above could be initiated and executed at tasks 210, 214.

It should be appreciated that the fluid infusion device processes theoutput levels associated with the force sensor to determine the currentoperating health of the force sensor. If the rewind force measurementfalls within the specified range (i.e., it is greater than the lowerthreshold force and less than the upper threshold force), then the fluidinfusion device can continue operating as usual. For example, the fluidinfusion device can complete the rewind operation (task 216, which maybe performed before or during tasks 206, 208, 210, 212, 214) beforeplacement of a new fluid reservoir into the fluid infusion device. Afterthe new fluid reservoir is installed, the process 200 activates areservoir seating operation (task 218) and uses the force sensor todetect when the new fluid reservoir is seated in the fluid infusiondevice. In this regard, the drive motor assembly is activated to advancethe slide until a predetermined seating force has been detected (task220). After detection of this seating force, the drive motor assemblycan be further advanced by an appropriate amount during a primingoperation, which is activated to prepare the fluid infusion device andthe new fluid reservoir for normal operation.

As mentioned above, a rewind operation and the related forcemeasurements could be performed before the fluid reservoir needs to bereplaced. If the process 200 determines that the force sensor isoperating as expected during such a rewind operation, then task 218 andtask 220 are performed to return the slide 121 to its former position incontact with the piston 144. Thereafter, fluid delivery may continue asthough the rewind operation never took place.

During normal use, the fluid infusion device regulates the delivery offluid from the fluid reservoir by controlling the movement of the drivemotor assembly (task 222). The same force sensor used to determine therewind force measurements can also be used to monitor for the onset ofan occlusion (task 224). In particular, the force imparted to the forcesensor (which is indicative of the pressure in the fluid reservoir) isdetermined and analyzed in accordance with one or more occlusiondetection schemes to detect an occlusion of the infusion set orelsewhere in the fluid delivery path.

In certain embodiments, the measured rewind forces (see task 206)observed during operation are recorded in the memory of the device. Thehistorical rewind force data may be used to detect trends and driftingin the measured rewind force, e.g., consistently decreasing,consistently increasing, random variation, or the like. Thus, even if ameasured rewind force does not trigger corrective action, the rewindforce values can be saved for diagnostic purposes, statisticalevaluation of the device, and the like.

The preceding description of the process 200 illustrates how rewindforce thresholds can be used to check the operating health of the forcesensor. The threshold forces may be fixed or adaptive (to accommodateand compensate for drifting of the force sensor). In this regard, FIG. 6is a flow chart that illustrates an embodiment of a rewind forcecalibration process 300 for a fluid infusion device, such as the fluidinfusion device 100. In certain scenarios, the process 300 is performedat least once during manufacturing of the fluid infusion device, and thecalibrated threshold forces are stored as fixed values for the life ofthe device. In other situations, the process 300 could be performedperiodically (e.g., at the request of the user, every year, or inaccordance with a maintenance schedule). The illustrated embodiment ofthe process 300 begins by performing a calibrating rewind operation(task 302). No fluid reservoir is present during calibration, and thedrive motor assembly is controlled as necessary to execute a rewindoperation.

During the calibrating rewind operation, the process 300 determines acalibration rewind force imparted to the force sensor (task 304). Task304 could obtain a single rewind force measurement at any time duringthe calibrating rewind operation, it could calculate an averagecalibration rewind force based upon any number of rewind forcemeasurements obtained during the calibrating rewind operation, or itcould generate any calibration rewind force value or metric that isbased upon one or more individual calibration rewind force measurementsobtained during the calibrating rewind operation. For simplicity, thisparticular embodiment of the process 300 assumes that a singlecalibration rewind force measurement is determined at task 304. If thecalibration period is finished (query task 306), then the process 300continues. If not, the process 300 performs another calibrating rewindoperation and determines a respective calibration rewind forcemeasurement for that operation. In other words, tasks 302, 304, 306 canbe repeated any desired number of times, resulting in a plurality ofcalibration rewind forces that can be saved for subsequent analysis andprocessing.

Upon completion of the calibration period, the process 300 calculates anominal rewind force from the plurality of calibration rewind forces(task 308). The nominal rewind force can be determined using any desiredformula, algorithm, relationship, or equation. For the simpleimplementation described here, the nominal rewind force is calculated asan average of the plurality of calibration rewind forces. As mentionedpreviously, the nominal rewind force is ideally equal or equivalent to aload of zero pounds on the drive motor assembly. Accordingly, anacceptable nominal rewind force will typically be within the range ofabout −0.50 to +0.50 pounds (this range is merely exemplary, and anembodiment could utilize different upper and/or lower values). In thisregard, the process 300 might check the calculated nominal rewind forceto ensure that it falls within a predetermined range of acceptablevalues. Thus, if the nominal rewind force falls outside of that range,the process 300 could generate an alarm, an alert, or a warning for theuser, and/or repeat the portion of the calibration routine associatedwith tasks 302, 304, 306, and 308.

Assuming that the calculated nominal rewind force is acceptable, it canbe stored in a memory element of the fluid infusion device (task 310)for future reference if needed. For this particular embodiment, theprocess 300 derives the lower threshold rewind force and the upperthreshold rewind force from the calculated nominal rewind force (task312). For example, the lower threshold force might be calculated bysubtracting a designated amount from the nominal rewind force, and theupper threshold force might be calculated by adding a designated amountto the nominal rewind force. Moreover, the manner in which thesethreshold forces are calculated could vary as a function of the nominalrewind force itself For instance, one threshold calculation scheme couldbe used when the nominal rewind force is greater than zero, and adifferent threshold calculation scheme could be used when the nominalrewind force is less than zero. After the rewind force thresholds havebeen derived, they can be stored in a memory element of the fluidinfusion device (task 314) for subsequent use as needed, e.g., duringexecution of the process 200. In practice, these rewind force thresholdscan be saved as fixed values that do not change during the operatinglife of the fluid infusion device. In this manner, the process 300results in a specified range of rewind forces that is indicative of ahealthy operating status of the force sensor.

In accordance with another approach, the operating health of the forcesensor 126 is checked more frequently, namely, at times other thanduring a rewind operation. This alternate approach (which may beutilized in conjunction with the first approach described above) checksthe health of the force sensor in an ongoing manner without having towait until a rewind operation. More particularly, this technique checksthe measured or detected force associated with the drive motor assemblyat designated motor pulses (e.g., at every motor pulse). If the measuredforce is below a predetermined value, the fluid infusion device willtake corrective action because this condition indicates that the forcesensor has drifted beyond its limit in the negative direction. If themeasured force is above a predetermined value, then the fluid infusiondevice assumes that the force sensor has drifted in the positivedirection, which might result in false or early detection of anocclusion.

FIG. 7 is a flow chart that illustrates another embodiment of a process400 associated with the operation of a fluid infusion device, such asthe fluid infusion device 100 described above. The process 400 may beginany time after activating a fluid delivery operation of the fluidinfusion device (task 402). During a fluid delivery operation, the drivemotor assembly is used to actuate the fluid reservoir in a controlledmanner. In certain implementations, fluid delivery operations arecarried out in a stepwise manner such that fluid is administered indiscrete fluid delivery strokes (or pulses) of the slide. In practice, afluid delivery operation may involve multiple fluid delivery strokes;the exact number will depend on the desired amount of fluid to bedelivered. Accordingly, the process 400 continues by performing the nextfluid delivery action, pulse, or stroke with the drive motor assembly(task 404), and determining and saving the corresponding measure ofactuation force imparted to the force sensor during that fluid deliveryaction (task 406).

Next, the process 400 compares the measure of actuation force to a rangeof valid values for the fluid infusion device (task 408). In practice,there will be a range of force sensor outputs or readings thatcorrespond to or otherwise represent normally expected measures ofactuation forces. For example, if the force sensor is operating asexpected, then it might have a limited and predetermined analog outputrange, which in turn corresponds to a limited and predetermined range ofencoded digital values. If, however, the force sensor is damaged, isbeginning to fail, or is otherwise operating in an unexpected or unusualmanner, then the resulting analog output and encoded digital valuescould be outside of the normally expected range. Measured values ofactuation force that are outside of the normally expected range aretherefore treated as invalid or undefined measures.

If the current measure of actuation force is not invalid as defined bythe particular settings and configuration of the fluid infusion device(query task 410), then the process 400 may return to task 404 to performthe next fluid delivery action. This enables the fluid infusion deviceto monitor the operating integrity of the force sensor during fluiddelivery and in an ongoing and dynamic manner If, however, the currentmeasure of actuation force is outside the range of valid values, thenthe process may generate a flag or otherwise record an invalid forceevent for the current measure of actuation force (task 412). Therecorded event may include information such as, for example, thedelivery time of the current stroke, the current measure of actuationforce, the current position of the slide or drive motor, or the like.Data associated with the recorded event can be saved for subsequentanalysis, for reporting purposes, for troubleshooting or diagnosticpurposes, etc. For instance, this embodiment of the process 400continues by analyzing a set of invalid force events to determine acourse of action for the fluid infusion device (task 414). In thisregard, the set of invalid force events may represent a designatednumber of past invalid force events, including the current invalid forceevent, collected over a particular period of time, collected for adesignated number of delivery strokes, or the like. In certainsituations, the set of invalid force events may correspond to only oneevent, which could be sufficient to trigger an alarm or an alert ifdeemed necessary. This allows the process 400 to initiate correctiveaction based on a single actuation stroke or pulse, based on an averagemeasure of multiple pulses, based on detected patterns of measuredforces, or the like. Task 414 may be performed to reduce the likelihoodof false alerts or false alarms associated with the operating health ofthe force sensor. In this regard, the process 400 may be used to detecta positive drift and/or a negative drift in the force sensor, which mayresult in the lack of timely alerts. Thus, the detection of only oneinvalid force event during an extended period of time or over the courseof many delivery strokes can be disregarded without triggering an alert.

The process 400 could utilize any type of criteria that influenceswhether or not a single invalid force event or a set of invalid forceevents will cause the fluid infusion device to respond. For example, thecriteria may dictate that at least a threshold number of invalid forceevents corresponding to consecutive fluid delivery actions must berecorded before a user alert is generated. As another example, thecriteria may dictate that at least a threshold number of invalid forceevents must be recorded within a designated period of time (such as 60minutes) before any corrective action is taken. The criteria may bechosen such that transient conditions that might influence the operationof the force sensor (e.g., handling of the device, bumping or droppingthe device, driving over a pothole, etc.) do not trigger an alarm.Rather, the criteria may be selected such that the fluid infusion deviceis given the opportunity to recover and settle from such transientevents.

Accordingly, if certain designated criteria is satisfied (query task416), then the process 400 can initiate and execute appropriatecorrective action at the fluid infusion device (task 418). If thecriteria has not been satisfied, then the process 400 may return to task404 to perform the next fluid delivery action. Thus, some form ofcorrective or remedial action can be taken in response to the recordingof one or more invalid force events, where the recorded events areindicative of poor operating health of the force sensor. Task 418 mayinitiate and execute any of the corrective actions described above fortasks 210 and 214 of the process 200.

The process 400 represents a simplified embodiment that analyzesactuation forces and checks for valid measures of actuation force fromone delivery stroke or pulse of the drive motor assembly to another.Alternative embodiments, however, could implement a more complex schemethat calculates and considers any suitable parameter, measure of force,force-related metric, or the like. For example, rather than compare theactuation forces to a range of valid measures per se, the fluid infusiondevice could instead calculate any appropriate parameter from themeasured actuation force, where the parameter is somehow indicative ofthe operating health of the force sensor, and then compare the value ofthat parameter to certain predetermined performance criterion for theforce sensor. If the parameter does not satisfy the performancecriterion, then the fluid infusion device can take corrective orremedial action.

In some embodiments, the fluid infusion device 100 is suitablyconfigured to check the operating condition of the force sensor 126using a known and calibrated force applied to the force sensor 126.Although not always required, this example assumes that the force sensor126 is tested after removing the fluid reservoir 111 and during a timewhen fluid need not be dispensed. Imparting a known nonzero calibrationforce to the force sensor 126 can be accomplished using any suitablecomponent, device, fixture, or equipment. In accordance with oneexemplary embodiment, the fitting 110 is replaced with a calibrationfitting that is provided with a precisely calibrated spring or otherelement that provides a known force at a specified amount of deflection.After installing the calibration fitting, the slide 121 is advanced by adesignated amount, which can be controlled by monitoring encoder countsor other metrics related to the operation of the drive motor 136. Whenthe slide 121 has advanced by the designated amount, the force element(e.g., the spring) is expected to impart the calibrating force to theslide 121, which in turn imparts the calibrating force to the forcesensor 126.

When the slide 121 has reached the calibration position, thecorresponding measure of actuation force is recorded and compared to avalue associated with the expected calibrating force. If the recordedvalue is different than the expected calibration value by more than astated amount, then the fluid infusion device 100 (and/or the user) canassume that the force sensor 126 is defective or otherwise notfunctioning according to specification. It should be appreciated thatthe calibration force should fall within the normal measuring range ofthe force sensor 126.

Reservoir Seating (Presence) Monitoring

The force sensor 126 in the fluid infusion device 100 may also beutilized to monitor the presence and seating status of the fluidreservoir 111. In this regard, the electronics module 162 of the fluidinfusion device 100 can be utilized to process the output levels of theforce sensor 126 to determine the seating status of the fluid reservoir111 in the reservoir cavity 134 in an ongoing manner. The fluid infusiondevice 100 can alert the user when the fluid reservoir 111 has beenaccidentally removed or inadvertently dislodged. The fitting 110 mightbe inadvertently rotated or loosened during physical activity (e.g.,while the user is playing a sport or exercising), which in turn mightresult in removal or dislodging of the fluid reservoir 111. When thishappens, proper coupling between the piston 144 of the fluid reservoir111 and the coupler 142 of the slide 121 could be lost. For safemeasure, the fluid infusion device 100 notifies the user shortly afterthe fluid reservoir 111 is partially removed, completely removed, ordislodged by more than a predetermined amount.

The fluid infusion device 100 uses the force sensor 126 to determine theseating status of the fluid reservoir 111. Accordingly, no additionalcomponents, sensors, or assembly time is needed to implement thisfeature. In certain embodiments, the fluid infusion device 100 uses ascheme that adaptively tracks the forces of delivery strokes. The fluidinfusion device 100 records the force of a delivery stroke. If themeasured force remains the same or increases from stroke-to-stroke, thenthe fluid infusion device 100 assumes that a fluid reservoir is in placeand is properly seated. Moreover, slight variations in the detectedforce can be disregarded to contemplate normal and expected forcevariations that typically occur along the travel path of a fluidreservoir. However, a characterized drop in force that is greater than acertain amount indicates that (1) the fluid reservoir 111 has beenremoved or dislodged or (2) the fluid infusion device 100 may have beendropped or bumped, temporarily disturbing the force sensor 126. For thesecond scenario, design engineers can characterize how many pulses(delivery strokes) and/or how much time is typically needed to allow thefluid infusion device 100 to recover from a disturbing impact or force,assuming that the fluid reservoir 111 remains present and properlyseated. If the measured force does not return to a nominal value after adesignated number of strokes or a predetermined amount of time, thefluid infusion device 100 can conclude that the fluid reservoir 111 hasbeen removed or disturbed and, in turn, generate an alert or a warningmessage for the user.

Notably, the reservoir presence scheme is adaptive in nature, and ittakes into account variations such as sensor drift, reservoir frictionalforce variation, and minor shocks. The reservoir presence methodologyactively monitors for an ongoing drop in force greater than a set value.This approach is desirable because it accommodates variations (such assensor drift) that might be introduced over the life of the fluidinfusion device 100, variations from one reservoir to another, andvariations (such as fluid pressure) that might occur during use of asingle reservoir. For example, if frictional force increases due toreservoir dynamics, the fluid infusion device 100 will adapt and set theincreased force measure as a new baseline value. Similarly, if thefrictional force is decreasing due to reservoir dynamics, the fluidinfusion device 100 will adapt the lower force measure as the newbaseline value (as long as the rate of decrease and/or the forcevariation is less than a specified amount). This feature accommodatesvariation in frictional force without false alarms. Accordingly, thefluid infusion device 100 adaptively resets the baseline force value aslong as the rates of change are within normal limits.

FIG. 8 is a flow chart that illustrates an embodiment of a process 500that checks the seating status of a fluid reservoir of a fluid infusiondevice, such as the fluid infusion device 100 described above. Theprocess 500 employs a simple force threshold for purposes of determiningthe seating status of the fluid reservoir. In this regard, the process500 may begin by obtaining, calculating, or accessing the forcethreshold (task 502), which represents an amount of force that isindicative of a dislodged, removed, displaced, or otherwise unseatedstate of the fluid reservoir. The force threshold may be adaptivelyupdated in response to certain operating conditions, it may be one of aplurality of different available threshold values, it may be apredetermined and fixed value, or the like. For this example, the forcethreshold is a pre-stored value that is fixed during the operatinglifespan of the fluid infusion device. In other embodiments (describedbelow), the force threshold can be calculated in a dynamic manner tocontemplate typical variations such as drifting of the force sensor.

Under typical operating conditions for exemplary embodiments, thenormally expected force imparted to the force sensor when the fluidreservoir is properly seated is less than about 1.5 pounds. Moreover,under typical operating conditions for exemplary embodiments, thenormally expected actuation force imparted to the force sensor during afluid delivery stroke is less than about 1.5 pounds. In certainimplementations, the force threshold used by the process 500 iscalculated as a function of the nominal seating force and/or as afunction of the nominal actuation force, and the force threshold isstored in a memory element of the fluid infusion device. For example,the force threshold might be calculated to be less than the averagefluid delivery actuation force by a given amount, such as a percentageof the average fluid delivery actuation force. As another example, theforce threshold is calculated such that it is a predefined amount offorce less than the nominal expected actuation force. In practice,regardless of the manner in which it is calculated, the force thresholdwill typically be less than about 0.5 pounds.

In practice, the process 500 can be initiated whenever a fluid reservoiris installed into the fluid infusion device. Accordingly, the process500 may confirm the initial seating of the fluid reservoir in thereservoir cavity (task 504). Task 504 may additionally (oralternatively) confirm when the fluid infusion device has performed apriming operation, which typically occurs after installation of a fluidreservoir. After confirming that the fluid reservoir has been properlyseated and/or otherwise properly installed, the fluid infusion devicewill eventually activate a fluid delivery operation, which in turnactuates the fluid reservoir with the drive motor assembly (task 506).As described in more detail above, actuation of the fluid reservoircauses an amount of force to be imparted to the force sensor.Accordingly, the process 500 determines a measure of actuation forceimparted to the force sensor during the fluid delivery operation (task508). Task 508 could obtain a single actuation force measurement at anytime during the fluid delivery operation, it could calculate an averageactuation force based upon any number of actuation force measurementsobtained during the fluid delivery operation (e.g., a plurality ofactuation forces corresponding to a plurality of consecutive deliverystrokes), or it could generate any actuation force value or metric thatis based upon one or more individual actuation force measurementsobtained during the fluid delivery operation. For simplicity, thisparticular embodiment of the process 500 assumes that a single actuationforce measurement is determined at task 508. For this example, task 508determines the measure of actuation force during the fluid deliverystroke itself. Alternatively (or additionally), task 508 could determinethe measure of actuation force between fluid delivery strokes, and/orafter a final fluid delivery stroke.

The process 500 may continue by comparing the actuation forcemeasurement to one or more threshold forces. For this example, theprocess 500 compares the measure of actuation force to an amount offorce (i.e., the force threshold obtained at task 502) that is less thanthe normally expected actuation forces of the fluid infusion device.Accordingly, the process 500 checks whether or not the measure ofactuation force (F_(A)) is less than the force threshold (F_(T)) atquery task 510. If the measure of actuation force is not less than theforce threshold, then the process 500 assumes that the fluid reservoiris still in place and remains properly seated. Accordingly, the process500 returns to task 506 to continue monitoring actuation force for thecurrent fluid delivery operation (and for subsequent fluid deliveryoperations). If, however, query task 510 determines that the measure ofactuation force is less than the force threshold and, therefore, thatthe measure of actuation force is indicative of an unseated state, thenthe fluid infusion device initiates and executes appropriate correctiveaction (task 512). The corrective action taken by the fluid infusiondevice may include, without limitation, one or more of the actionsdescribed above for the process 200 (see FIG. 5). It should beappreciated that the process 500 may consider any number of events(i.e., determinations that the measure of actuation force is less thanthe force threshold) and analyze a set of events to determine whether ornot to initiate the corrective action. In this regard, the process 500may determine whether a set of events satisfies certain predeterminedcriteria before taking corrective action, as described above withreference to tasks 412, 414, and 416 of the process 400.

The process 500 is one exemplary embodiment that utilizes a fixed forcethreshold value to determine whether or not the fluid reservoir isseated. In contrast, FIG. 9 is a flow chart that illustrates anotherembodiment of a process 600 that employs an adaptive scheme for checkingthe seating status of the fluid reservoir. The process 600 can beperformed whenever a fluid reservoir is installed into the fluidinfusion device. Thus, the process 600 may begin by confirming theinitial seating and priming of the fluid reservoir (task 602), andactivating a fluid delivery operation (task 604), as described above forthe process 500. After initial seating of the fluid reservoir, theprocess obtains a baseline actuation force imparted to the force sensor(task 606). The baseline actuation force may correspond to a measure ofactuation force that is obtained during the priming operation or shortlythereafter, or it may correspond to a measure of actuation force that isobtained during the first fluid delivery operation for a new fluidreservoir. The process 600 assumes that the baseline actuation force ismeasured while the fluid reservoir is properly seated. Accordingly, thebaseline actuation force can be stored in a memory element of the fluidinfusion device for later use.

Eventually, the process 600 determines a measured actuation forceimparted to the force sensor, where the measured actuation forcecorresponds to a designated delivery stroke of the drive motor assembly(task 608). Task 608 could obtain a single actuation force measurementat any time during the fluid delivery operation, it could calculate anaverage actuation force based upon any number of actuation forcemeasurements obtained during the fluid delivery operation (e.g., aplurality of actuation forces corresponding to a plurality ofconsecutive delivery strokes), or it could generate any actuation forcevalue or metric that is based upon one or more individual actuationforce measurements obtained during the fluid delivery operation. Forsimplicity, this particular embodiment of the process 600 assumes that asingle actuation force measurement is determined at task 608. Asmentioned previously, the actuation force could be determined during thefluid delivery stroke itself, between fluid delivery strokes, or after afinal fluid delivery stroke.

The process 600 may continue by comparing the actuation forcemeasurement to a measure of force that is influenced by the baselineactuation force (F_(B)). For this example, the process 600 checks (querytask 610) whether the measured actuation force (F_(A)) is less than thebaseline actuation force by some predetermined amount (F_(T)), which maybe a fixed, adaptive, or dynamic threshold, as explained above for theprocess 500. In other words, query task 610 determines whetherF_(A)<F_(B)−F_(T). If query task 610 determines that the measure ofactuation force is indicative of an unseated or dislodged fluidreservoir, then the fluid infusion device initiates and executesappropriate corrective action (task 612), e.g., generates an alert orsome indicia of an unseated fluid reservoir. Alternatively oradditionally, the corrective action taken by the fluid infusion devicemay include, without limitation, one or more of the actions describedabove for the process 200 (see FIG. 5). It should be appreciated thatthe process 600 may consider any number of events (i.e., individualdeterminations that F_(A)<F_(B)−F_(T)) and analyze a set of events todetermine whether or not to initiate the corrective action. In thisregard, the process 600 may determine whether a set of events satisfiescertain predetermined criteria before performing task 612 (see the abovedescription of tasks 412, 414, and 416 of the process 400).

If the measure of actuation force is indicative of a properly seatedfluid reservoir, then the process 600 updates the baseline actuationforce as a function of the measured actuation force (task 614). For thisparticular embodiment, task 614 updates the baseline actuation force bysaving the measured actuation force for use as the next baselineactuation force. In practice, the fluid infusion device could implementa maximum and/or a minimum allowable baseline actuation force to ensurethat the process 600 maintains a realistic baseline value. If for somereason the measured actuation force falls outside of the stated range ofbaseline force values, the fluid infusion device could generate an alertor take appropriate action. In this regard, a maximum or minimum valuecould serve as a confirmation or check of the operating health of theforce sensor (see the Sensor Health Monitoring section of thisdescription). Referring back to task 614, after updating the baselineactuation force, the process 600 returns to task 708 to continuemonitoring actuation force for the current fluid delivery operation (andfor subsequent fluid delivery operations). Thus, the baseline actuationforce is adjusted and updated in an ongoing manner while the process 600monitors the seating status of the fluid reservoir. This adaptiveapproach enables the process 600 to consider and compensate for slightvariations in measured actuation forces.

FIG. 10 is a flow chart that illustrates yet another embodiment of aprocess 700 that checks the seating status of a fluid reservoir. Theprocess 700 uses a threshold force value that corresponds to the maximumexpected variation in actuation force for the fluid reservoir. Thisthreshold force value may be empirically determined, calculated based onknown operating parameters of the fluid infusion device, or generatedand dynamically updated during operation of the fluid infusion device.In certain embodiments, the threshold force value is determined andstored as a fixed value during the operating lifespan of the fluidinfusion device. For example, and without limitation, the typical fluiddelivery force for a fluid reservoir might be about 1.4 pounds betweeninitial piston seating and depletion of the fluid reservoir, and thethreshold force value might be about 0.2 pounds.

The process 700 obtains the measures of actuation force imparted to theforce sensor for consecutive fluid delivery pulses (in practice, ameasure of actuation force is recorded for each fluid delivery pulse).The process 700 calculates a pulse-to-pulse difference betweenconsecutive fluid delivery pulses, where the pulse-to-pulse differenceis based on respective measures of actuation force for the consecutivefluid delivery pulses. If the pulse-to-pulse difference is greater thanthe designated threshold force value, then the fluid infusion deviceinitiates corrective action in some manner. In other words, if thedifference in actuation force between the last fluid delivery pulse andthe current fluid delivery pulse is more than the normally expectedforce variation, then the fluid infusion device assumes that thedetected condition is indicative of a dislodged or removed fluidreservoir, or a transient state caused by an impact or suddenacceleration to the fluid infusion device. Note that in order to assumea removed or dislodged reservoir, the difference in force from one pulseto the next must be negative, i.e., the measured force has decreasedrather than increased.

The process 700 may include some tasks that are similar or identical tocounterpart tasks found in the process 600, and such tasks will not beredundantly described here. The process 700 assumes that the fluidreservoir has already been properly seated for fluid delivery. Thisembodiment of the process 700 begins by initializing and maintaining acount (task 702) that is indicative of the seating status of the fluidreservoir. The count may be initialized at any suitable value, althoughthis example assumes that the count is initialized at a value of zero.The process 700 also sets the value of PULSE1 to “True” (task 702). Thevalue of PULSE1 is True only for the first actuation pulse followinginstallation of a fluid reservoir. For all subsequent delivery pulses,the value of PULSE1 is False. The fluid infusion device is primed (task704) such that fluid is introduced into the fluid pathway and throughthe infusion set tubing. During priming, the force imparted to the forcesensor typically spikes (to about 1.4 pounds) when the slide initiallycontacts the plunger of the reservoir. After priming, however, the forcedecays and settles to a lower value (typically around 0.5 pounds).

The process 700 activates a fluid delivery operation (task 706) toactuate the fluid reservoir, and performs the next fluid deliveryaction, stroke, or pulse (task 708). As explained in more detail below,tasks 706 and 708 are usually performed after the priming operation iscomplete and after the force has settled to its nominal value (of about0.5 pounds). If, however, the user commands a fluid delivery operationprematurely while the force is still decaying, then the force impartedto the force sensor at that time may be above the nominal value. Theprocess 700 contemplates this scenario, as described below.

The process 700 continues by determining or obtaining a current measureof actuation force imparted to the force sensor for the current fluiddelivery pulse (task 710), as described previously. The current measureof actuation force (F) is recorded or saved in an appropriate manner. IfPULSE1 is True (query task 712), meaning that the pulse actuated at task708 is the first pulse for the installed reservoir, then the process 700continues by setting the value of PULSE1 to “False” (task 714), and bycomparing the current measure of actuation force (F) to a referenceupper threshold force value that applies to initial pulses (RUT1), asindicated by query task 716. The value of RUT1 is selected to accountfor situations where the initial pulse is commanded prematurely, i.e.,before the force has settled to its nominal value after priming. Inother words, RUT1 is selected to contemplate the possibility ofunusually high force measurements associated with the first pulsecommanded for a newly installed reservoir. For this particular example(where the normally expected nominal actuation force for the fluidreservoir is about 0.4 pounds), the value of RUT1 may be chosen to beabout 0.5 pounds, without limitation.

If the current measure of actuation force is less than RUT1 (query task716), then the process 700 stores the current measure of actuation force(task 718) for use as an adaptive reference force value (F_(R)), whichis used for comparison purposes against subsequent force measurements.Execution of task 718 indicates that the actuation force associated withthe initial delivery pulse does not represent a force measured shortlyafter priming, while the fluid in the delivery path is still settling toits nominal state. On the other hand, if the current measure ofactuation force (F) is not less than RUT1 (query task 716), then theprocess 700 stores the value of RUT1 as the current value of F_(R) (task720). Execution of task 720 indicates that the actuation forceassociated with the initial delivery pulse may have been sampled duringa time when the fluid in the delivery path is still settling and,therefore, the measured force is still decaying from the relatively highvalue (e.g., about 1.4 pounds). Consequently, under this scenario theprocess 700 uses RUT1 as the current adaptive reference force value.

After the value of F_(R) has been set (task 718 or task 720), theprocess 700 waits for the next fluid delivery pulse (task 722). When itis time to perform the next fluid delivery pulse, the process 700returns to task 708 and continues as described above. In contrast tothat described above, however, the value of PULSE1 is False for thesecond and all further delivery pulses. Referring again to query task712, if PULSE1 is not True (i.e., PULSE1=False), then the process 700may continue by comparing the current measure of actuation force to thedifference between the adaptive reference force value (F_(R)) and athreshold force value (query task 724). For this example, the adaptivereference force value (F_(R)) may correspond to a past measure ofactuation force that was recorded for a previous fluid delivery pulse,or it may correspond to RUT1, as described above. In particularembodiments, F_(R) might represent the measure of actuation force forthe immediately preceding fluid delivery pulse (indeed, under normaloperating conditions where the fluid reservoir remains properly seated,F_(R) will be adaptively updated to reflect the most recent measure ofactuation force). In other words, the previous fluid delivery pulseassociated with F_(R) and the current fluid delivery pulse willtypically be consecutive fluid delivery pulses. Thus, the process 700stores, maintains, and updates the adaptive reference force value asneeded during operation of the fluid delivery device.

In practice, the process 700 might generate or store an initial value ofF_(R) whenever a new fluid reservoir is installed, at the beginning of afluid delivery operation, at designated times, at the request of theuser, or at other appropriate times. This example assumes that F_(R) isinitialized as described above in response to the first fluid deliverypulse of a fluid delivery operation. Thus, under typical and normaloperating conditions the first measure of actuation force will be usedas F_(R) for the immediately following fluid delivery pulse. If,however, the first measure of actuation force exceeds the initial upperthreshold value, then the initial upper threshold value RUT1 willinstead be used as F_(R) for the next fluid delivery pulse.

Referring again to query task 724, if the current measure of actuationforce (F) is not less than the difference between the adaptive referenceforce value (F_(R)) and the threshold force value (F_(T)), then theprocess 700 assumes that the fluid reservoir remains properly seated.Accordingly, the process 700 resets the count to its initial value,e.g., zero (task 726). The illustrated embodiment of the process 700continues by comparing the current measure of actuation force (F) to anupper threshold force value (RUT), as indicated by query task 728. Thisupper threshold value is selected such that it is indicative of theexpected maximum actuation force for the fluid reservoir. For thisparticular example (where the normally expected actuation force for thefluid reservoir is about 1.4 pounds), the upper threshold force valuemay be chosen to be about 1.8 pounds, without limitation. If the currentmeasure of actuation force is less than the upper threshold force value,the process 700 stores the current measure of actuation force for use asF_(R) with the next iteration (task 730). In this regard, F_(R) can beadaptively and dynamically updated in an ongoing manner during the fluiddelivery operation. After updating F_(R), the process 700 waits until itis time to perform the next fluid delivery pulse (task 722). Referringback to query task 728, if the current measure of actuation force is notless than the upper threshold force value, then the process 700 leavesF_(R) unchanged and waits for the next fluid delivery pulse (task 722).In other words, the previous value of F_(R) is retained for the nextprocessing iteration. When it is time to perform the next fluid deliverypulse, the process 700 returns to task 708 and continues as describedabove.

Referring again to query task 724, if F<F_(R)−F_(T), then the process700 initiates some form of corrective action, which is triggered by thedetection of an abnormal or unexpected measure of actuation force. Inthis regard, the process 700 may place the fluid infusion device into aflagged state, perform additional checks, and/or perform additional dataanalysis to determine whether or not to execute corrective action, issuean alert, sound an alarm, generate a user message, etc. This particularexample continues by obtaining one or more additional force readings(task 732) and calculating an average measure of actuation force(F_(AVE)) based on the additional force readings. In practice, F_(AVE)may be calculated from the current measure of actuation force and any orall of the additional force readings. In certain embodiments, task 732collects four additional force readings, and F_(AVE) is calculated as aweighted average of the current measure of actuation force and the fourrepeated measures of actuation force imparted to the force sensor.

Although the process 700 could use the current measure of actuationforce itself as a trigger value, the illustrated embodiment instead usesF_(AVE) as the trigger value. In other words, the process 700 checkswhether F_(AVE)<F_(R)−F_(T) (query task 734). If F_(AVE) is not lessthan the difference between the adaptive reference force value (F_(R))and the threshold force value (F_(T)), then the process 700 assumes thatthe fluid reservoir remains properly seated, resets the count to itsinitial value (task 726), and continues from task 726 as describedabove. If, however, F_(AVE)<F_(R)−F_(T), then the process 700 changesthe count by a designated amount to obtain an updated count (task 736).Depending upon the embodiment and the initial count value, task 736 mayincrease or decrease the count. In certain embodiments, task 736 changesthe count by an amount that is influenced or dictated by a volume offluid to be delivered by a subsequent fluid delivery pulse, e.g., thenext fluid delivery pulse. Alternatively, task 736 might change thecount by an amount that is influenced or dictated by a volume of fluiddelivered by the current fluid delivery pulse, or by a previous fluiddelivery pulse. In accordance with one non-limiting example, task 736increases the count by one when the next fluid delivery pulsecorresponds to a relatively low volume of fluid (e.g., 0.025 units),increases the count by two when the next fluid delivery pulsecorresponds to a relatively intermediate volume of fluid (e.g., 0.050units), and increases the count by six when the next fluid deliverypulse corresponds to a relatively high volume of fluid (e.g., 0.200units).

The above methodology for task 736 accounts for “slack” that is createdin the drive system when the fluid infusion device is dropped or whenthe reservoir is dislodged. For example, assume that the slackrepresents a separation between the plunger of the reservoir and the tipof the actuating slide, and assume that it takes six pulses (eachcorresponding to a delivery of 0.025 Units), equivalent to 0.15 Units,to remove the slack. Therefore, the counter limit or threshold will beset to six. If after six “counts” the slack is not removed, i.e., theforce is still low, the process 700 will trigger an alarm. If the devicedelivers fluid in 0.025 Unit pulses, it will take six pulses and,therefore, the count is incremented by one. On the other hand, if thefluid delivery is in 0.05 Unit increments, then the counter isincremented by two; if the fluid delivery is in 0.2 Unit pulses, thecounter increments by six. Accordingly, the limit or threshold is metafter six 0.025 Unit pulses, after three 0.05 Unit pulses, or after onlyone 0.2 Unit pulse. This allows the fluid infusion device to delivervarious pulses and increment correctly.

After obtaining the updated count, the process 700 checks whether theupdated count satisfies certain predetermined alert criteria (query task738). The alert criteria for the illustrated embodiment is simply athreshold count value or a limit, such as twelve or any appropriatenumber. Thus, if the updated count is greater than the limit, then theprocess 700 assumes that the fluid reservoir has been dislodged,loosened, or unseated. Consequently, the process 700 initiates andexecutes appropriate corrective action (task 740), e.g., generates aseating status alert or some indicia of an unseated fluid reservoir.Alternatively or additionally, the corrective action taken by the fluidinfusion device may include, without limitation, one or more of theactions described above for the process 200 (see FIG. 5). If, however,query task 738 determines that the updated count does not satisfy thestated alert criteria, then the process 700 does not actually implementor execute any corrective action at this time. Rather, the process 700may lead back to task 722 to wait for the next fluid delivery pulse, asdescribed above. Notably, corrective action is executed by theillustrated embodiment of the process 700 only when the count exceedsthe threshold limit. Moreover, the manner in which the count is reset bythe process 700 ensures that unexpectedly low actuation force readingsmust be recorded for consecutive fluid delivery pulses before the fluiddelivery device actually issues a warning or an alert. These aspects ofthe process 700 reduce nuisance alerts and allow the fluid infusiondevice to recover from transient conditions that might cause a temporarydrop in the measured actuation force (e.g., dropping or bumping thefluid infusion device, mishandling the fluid infusion device, or thelike). In certain embodiments, if at any point when the force is low andthe count is being updated the force increases (i.e., the slide contactsthe plunger of the reservoir), the counter is again reset to zero.

FIG. 11 is a graph that illustrates measures of actuation forces for aproperly seated fluid reservoir. The plot 800 represents actuation forceversus time (or, equivalently, fluid delivery pulses). The initialportion 802 of the plot 800 corresponds to the seating of the fluidreservoir. In practice, the device stops the seating process when aforce of about 1.4 pounds is reached. Momentum of the motor results insome additional actuation, resulting in a peak of about 1.8 pounds.After seating and priming, however, the nominal force typically settlesto about 0.5 pounds. Accordingly, the label P₁ represents the firstfluid delivery pulse following the seating/priming procedure. The dashedline 804 schematically represents the threshold force valuecorresponding to the allowable drop in actuation force over any twoconsecutive fluid delivery pulses. Notably, even though the plot 800fluctuates somewhat, the actuation force values do not violate the limitdefined by the threshold force value. In other words, the plot 800 isindicative of a properly seated fluid reservoir under normal andexpected operating conditions.

In contrast, FIG. 12 is a graph that illustrates measures of actuationforces for a fluid reservoir that becomes unseated. The plot 850 beginsat a point after initial seating of the fluid reservoir. The initialsegment 852 of the plot 850 is indicative of a properly seated fluidreservoir (assuming that the threshold force value is 0.15 pounds). Theplot 850 experiences a temporary drop 854 that spans two fluid deliverypulses. For this example, the temporary drop 854 would trigger thecounting mechanism described above with reference to the process 700.However, the plot 850 recovers after the temporary drop 854 and,therefore, the count would be reset and no alert would be generated. Atthe fluid delivery pulse 856, the plot 850 exhibits a significant and“permanent” drop. At this point, the counting mechanism would beactivated. Notably, the drop in measured actuation force does notrecover even after ten consecutive fluid delivery pulses. Consequently,the count continues to increase and, for this example, the upper countlimit is eventually reached. At that time, the fluid infusion devicewould generate an appropriate alert, alarm, or warning message, asdescribed previously.

Adaptive Occlusion Detection

The force sensor 126 and/or other sensors, measurement devices, orcomponents in the fluid infusion device 100 may also be used forpurposes of occlusion detection. Most conventional occlusion detectionschemes function by triggering an occlusion alarm when a certain presetthreshold force is reached. For example, if the typical actuation forcefor a fluid reservoir is about one pound and the occlusion threshold isthree pounds, a detected force that exceeds three pounds will initiatean alert or an alarm. In fluid infusion devices that are occluded, theforce might increase by only fractions of a pound per unit of fluid(e.g., insulin) desired to be delivered. As a result, there canpotentially be long wait times before an occlusion is actuallyconfirmed.

In contrast, the technique described here is adaptive in nature, andocclusions can be determined prior to reaching the preset threshold byevaluating consecutive rates of change (slopes) of force. For example,assume that the typical force variation in a reservoir is only about0.02 pound per unit (lb/U) over three or four delivery strokes orpulses. If an occlusion is present, the detected force might increase ata calculated rate of 0.30 lb/U over four consecutive pulses. If thefluid infusion device detects an occlusion, then an alarm might begenerated and/or the occlusion force threshold might be adjusteddownward by a certain amount. For example, if the normal occlusionthreshold is three pounds, a detected occlusion condition might resultin a downward adjustment of the occlusion threshold by thirty percent,resulting in an adjusted occlusion threshold of about two pounds. Theadaptive approach enables the fluid infusion device to quickly detect anocclusion, relative to traditional methods that only use a static forcethreshold.

FIG. 13 is a flow chart that illustrates an embodiment of an occlusiondetection process 900 for a fluid infusion device, such as the fluidinfusion device 100 described above. This embodiment of the process 900employs an occlusion force threshold, which is consistent withtraditional methodologies. Thus, the process 900 may begin by obtaining,calculating, or retrieving the occlusion force threshold (task 902). Intypical implementations this occlusion force threshold is about 2.4pounds, although the actual amount may vary from one embodiment toanother.

In practice, the process 900 can be performed whenever a fluid reservoiris installed into the fluid infusion device. Accordingly, the process900 may confirm the initial seating and/or priming of the fluidreservoir (task 904), and then activate a fluid delivery operation,which in turn actuates the fluid reservoir with the drive motor assembly(task 906). As described in more detail above, actuation of the fluidreservoir causes an amount of force to be imparted to the force sensor.Accordingly, the process 900 determines and saves actuation forces for adesignated number of delivery strokes (task 910). This particularembodiment determines and saves actuation forces for a plurality ofconsecutive delivery strokes and then determines an average actuationforce for the plurality of delivery strokes (task 912).

The process 900 may continue by comparing the average actuation force(F_(AVE)) to the occlusion force threshold (F_(T)) obtained at task 902.If the average actuation force is greater than the occlusion forcethreshold (query task 914), then the fluid infusion device initiates andexecutes appropriate corrective action (task 916). The corrective actiontaken by the fluid infusion device may include, without limitation, oneor more of the actions described above for the process 200 (see FIG. 5).If, however, query task 914 determines that the average actuation forceis not greater than the occlusion force threshold, then the process 900continues.

The process may continue by analyzing the actuation force and the amountof fluid (typically expressed as a number or fraction of units) that isdesired to be administered for delivery (task 918). As mentioned above,the process 900 analyzes the rate of change of a metric corresponding tothe amount of detected force per unit of fluid (as commanded by thefluid infusion device). In this regard, the process 900 may compute thismetric (e.g., in lb/U) in an ongoing manner during the fluid deliveryoperation. Moreover, the process 900 calculates the rate of change ofthis metric in an ongoing manner during the fluid delivery operation.Consequently, if the fluid infusion device determines that the rate ofchange exceeds a predetermined maximum value (query task 920), then theprocess 900 leads to task 916 and initiates appropriate correctiveaction. If, however, query task 920 determines that the rate of changedoes not exceed the maximum value, then the process 900 assumes that thefluid delivery path is not occluded. Accordingly, the process 900returns to task 910 to continue monitoring actuation forces for thecurrent fluid delivery operation (and for subsequent fluid deliveryoperations). The maximum tolerable rate of change may be a fixed valueor it may be adaptive in nature. In typical embodiments, the maximumrate of change value will be about 1.0 lb/unit, although differentvalues could be used depending upon the embodiment.

It should be appreciated that the process 900 may be practiced inconjunction with conventional occlusion detection schemes if so desired.For example, one or more of the occlusion detection approaches describedin U.S. Pat. Nos. 6,485,465 and 7,621,893 (or modified versions thereof)could be employed with the process 900.

Multi-Metric Occlusion Detection

The force sensor 126 in the fluid infusion device 100 may also be usedto support a multi-metric occlusion detection scheme. The multi-metricocclusion detection approach may be used with or without a traditionalreservoir force threshold approach. One benefit of the multi-metrictechnique is that it accommodates drifting or other changes of the forcesensor, which might occur over the lifespan of the fluid infusion device100. In practice, therefore, the multi-metric technique can toleratedrifting of the force sensor without generating false alarms, whilestill accurately detecting the presence of an occlusion.

The exemplary approach presented here employs a rate of changemethodology incorporating two different conditions to take advantage ofthe rate of change in force with respect to fluid delivery. If either ofthe two conditions is satisfied, the fluid infusion device 100 indicatesan occlusion and takes appropriate action. The rate of change approachis desirable because it does not depend solely on the system to settleto a force level. Moreover, the approach described here does not rely onthe starting frictional force of a reservoir. In practice, differentreservoirs might have different nominal actuation forces; for example,reservoir A may have running force of 1.0 pound, and reservoir B mayhave a running force of 1.8 pounds. Based on a simple threshold forcealone, it will take more time for reservoir A to reach occlusion thanreservoir B. Using the rate of change approach presented here, as longas the threshold rate of change is reached, occlusion will be detectedindependent of starting frictional force value.

The first monitoring mode uses one rate of change of reservoir force asa triggering parameter, where the rate of change is determined for arelatively large delivery window. For example, assume that the measuredrate of change in force over fluid delivery in a three-unit (3 U) windowis not to exceed 0.375 lb/unit. If, over any three-unit window, the rateof change exceeds 0.375 lb/unit, the fluid infusion device 100 alarms.It is desirable to have a predetermined measurement window (3 U in thiscase) because during normal delivery there might be some sudden changesin force. In this regard, a reservoir might experience a running forceof 1.0 pound and suddenly increase to 1.3 pounds over a delivery windowof 0.5 units, and continue to deliver at 1.3 pounds. This scenario wouldnot be indicative of an occlusion; rather, this would be indicative of anormal variation in force. If the measurement window of three units isnot utilized, this scenario could have led to a false occlusion alarm.

In practice, the measurement window and the rate of change thresholdshould be large enough to avoid false positives. However, most of thetime these parameters can be more restrictive. Accordingly, theexemplary embodiment described here utilizes the second monitoring mode,which employs a different rate of change threshold and a smallermeasurement window, along with a threshold force value that serves as an“early” indication of a possible occlusion. For the exemplary embodimentdescribed here, if a reservoir is known to be operating at actuationforces beyond its normal range (for example above 1.4 pounds), then thesecond condition will be considered. For example, if the measuredactuation force is 1.8 pounds, the fluid infusion device 100 recognizesthat the nominal operating load has been exceeded, but the fluidinfusion device 100 does not determine the presence of an occlusionbased solely on this high force reading (high forces can be caused by anoverly sensitive force sensor, among other reasons). If, however, therate of change of the force also exceeds a predetermined thresholdvalue, then the fluid infusion device 100 alarms. In this scenario, therate of change and the measurement window can be selected for higherdetection sensitivity because the fluid infusion device 100 is alreadyoperating at a higher than normal reservoir actuation force. The secondcondition is based on the observation that a reservoir that is over theforce limit and also experiencing an increasing rate of change in forceis most likely to be occluded.

The multi-rate approach presented here allows the fluid infusion device100 to tolerate actuation forces that are slightly above the nominalreservoir force range, yet not generate an alarm unless one of theconditions (with different measurement windows and different rates ofchange of force) is met. This approach allows the fluid infusion device100 to experience a slightly higher force due to mechanical issues,normal lifespan variation, and/or an oversensitive force sensor, whilecontinuing to function within safe and predictable limits.

FIG. 14 is a flow chart that illustrates an exemplary embodiment of amulti-mode occlusion detection process 1000 for an infusion device, suchas the fluid infusion device 100. The process 1000 may be performed inconnection with any fluid delivery operation or action, such as thedelivery of therapy, the priming of the fluid path, the initializing ofa new fluid reservoir, or the like. Accordingly, the process 1000 maybegin by initiating or activating a fluid delivery action (task 1002) todeliver a designated or commanded amount of fluid from the fluidreservoir. The fluid delivery action actuates the fluid reservoir withthe drive motor assembly, as described previously. The fluid deliveryaction may be stepwise or continuous, depending upon the particularembodiment. This example assumes that the fluid reservoir is actuated ina stepwise or pulsed manner, with a series of discrete actuation strokesthat collectively result in the desired amount of fluid delivered fromthe reservoir.

During the fluid delivery action the process 1000 determines, obtains,or samples one or more measures of actuation force, using the forcesensor (task 1003). Each measure of force corresponds to an output levelrecorded from the force sensor. In practice, therefore, a measure offorce (also referred to here as a “force measurement”) may be a voltage,a current, a capacitance, a resistance, a digital value, an analogvalue, or any detectable characteristic of the force sensor that somehowindicates the actuation of pressure in the fluid reservoir. Theexemplary embodiment determines a plurality of force measurements duringthe commanded fluid delivery action, and each force measurement also hasan associated quantity metric or measurement (e.g., a delivered volumeof fluid relative to a reference volume or other reference point).Alternatively (or additionally), each force measurement might beassociated with a corresponding time, delivery stroke, or othermeasurable parameter that can be used to calculate a rate of change ofthe actuation force.

The process 1000 detects an occlusion in one of two different modesassociated with different measurement windows. As used here, a“measurement window” may refer to one or more of the following, withoutlimitation: a period of time; a delivery time relative to a referencetime; a measure of quantity (e.g., a delivered volume, mass, or weight);an amount of travel or distance associated with actuation of the pistonof the fluid reservoir; a number, a count, or other parameter associatedwith turns or rotation of the drive motor assembly; a measured amount offluid flow; or the like. For the exemplary embodiment described here,the measurement windows represent a volume of fluid dispensed from thefluid reservoir. Moreover, each measurement window is identifiedrelative to a reference volume measurement.

FIG. 15 is a graph that depicts an exemplary plot 1050 of fluidreservoir actuation force versus volume of fluid (units) delivered froma fluid infusion device. FIG. 15 illustrates the concept of measurementwindows. For example, a measurement window 1052 is defined such that itcorresponds to a delivered volume of 3.0 units. This measurement window1052 may be defined by the current state of the fluid infusion deviceand a previous state of the fluid reservoir. For this example, thecurrent state of the fluid infusion device corresponds to the pointwhere 5.0 units have been delivered, and the previous state correspondsto the point where 2.0 units have been delivered, i.e., the state whenthe fluid reservoir had 3.0 more units of fluid. Each measurement windowmay correspond to a moving window that tracks the real-time status ofthe fluid infusion device and the real-time status of the fluidreservoir. Thus, as the fluid reservoir progresses from its “full” stateto its “empty” state, a measurement window can move to contemplate anytwo moving endpoints that define the predetermined volume (for theexemplary embodiment, one of the two endpoints corresponds to thecurrent state, the current force measurement, and the current volumemeasurement).

The exemplary embodiment of the process 1000 employs two differentmeasurement windows, e.g., a large window and a small window. For easeof understanding, FIG. 15 depicts two measurement windows relative to apoint at which 15.0 units have been delivered from the fluid reservoir.The large (3.0 units) window 1054 and the small (1.0 unit) window 1056are both measured relative to the current measurement point of 15.0units. Referring again to FIG. 14, if the rate of change of the measureof force (based on the large window) is greater than or equal to a firstthreshold value (query task 1004), then the process 1000 indicates anocclusion (task 1006) and initiates and executes appropriate correctiveaction (task 1008). The corrective action taken by the fluid infusiondevice may include, without limitation, one or more of the actionsdescribed above for the process 200 (see FIG. 5). If the rate of changeis less than the first threshold value (the “No” branch of query task1004), then the process 1000 may proceed to a query task 1010, whichcompares the rate of change of the measure of force (based on the smallwindow) to a second threshold value. More specifically, the process 1000indicates an occlusion (task 1006) if: (a) the rate of change of themeasure of force (based on the small window) is greater than or equal tothe second threshold value; and (b) the current force measurement isgreater than or equal to a threshold force value. For this particularembodiment, the first rate of change threshold value is greater than thesecond rate of change threshold value.

If the first rate of change is less than the first threshold value andthe second rate of change is less than the second threshold value (the“No” branch of query task 1010), then the process 1000 may check todetermine whether more delivery strokes or pulses are needed for thecurrent fluid delivery operation (query task 1012). If more deliverystokes are required, then the process 1000 waits for and executes thenext fluid delivery pulse and returns to task 1003 to continue asdescribed above. If there are no additional delivery strokes required,then the process 1000 ends.

The above description of the process 1000 assumes that the small andlarge windows are fixed in size. In certain embodiments, however, thesmall and/or large window size could vary as a function of the currentforce measurement. For example, as the current measured force increases,the small window size may decrease. Similarly, the first threshold slopevalue and/or the threshold slope value could vary as a function of thecurrent force measurement if so desired.

The process 1000 represents a simplified and generalized version of amulti-mode occlusion detection technique. In practice, a fluid infusiondevice could carry out an occlusion detection process having moredetailed steps and specific operating parameters. In this regard, FIG.16 is a flow chart that illustrates another exemplary embodiment of amulti-mode occlusion detection process 1100. The following descriptionutilizes certain parameters and settings for an exemplaryimplementation. These parameters and settings are not intended to limitor otherwise restrict the scope or application of the described subjectmatter in any way. The parameters, settings, and variables used in thefollowing description of the process 1100 are:

F₀=initial force measurement

F_(TH) _(—) ₀=4.0 pounds=initial force limit or threshold

F_(TH) _(—) _(D)=4.0 pounds=gross delivery force limit or threshold

i=index variable

F(i)=current force measurement

F_(TH)=1.8 pounds=threshold force value

U(i)=delivered volume measurement, relative to a reference volume

W_(SM)1.5 unit=small volume window

W_(LG)=3.0 units=large volume window

S_(SM)=calculated slope for the small window

S_(LG)=calculated slope for the large window

S_(TH) _(—) _(SM)=0.220 lb/U=threshold slope value for the small window

S_(TH) _(—) _(LG)=0.380 lb/U=threshold slope value for the large window

The process 1100 may be performed in connection with any fluid deliveryoperation or action and, as such, the process 1100 may begin byinitiating a fluid delivery action (task 1102) to deliver a designatedor commanded amount of fluid from the fluid reservoir. At this point,fluid need not be actually delivered. Rather, the process 1100 isinitiated when the system intends to deliver fluid to check whether ornot an occlusion is present before actually delivering fluid. Theprocess 1100 determines, measures, or obtains a plurality of forcemeasurements during the fluid delivery operation of the drive motorassembly, including an initial force measurement (F₀) and at least onesubsequent force measurement. The illustrated embodiment performs aninitial gross occlusion check before or at the beginning of each fluiddelivery action. To this end, the process 1100 determines the initialforce measurement (task 1104), which indicates an initial measure ofactuation force imparted to the force sensor, and compares the initialforce measurement (F₀) to the initial force limit (F_(TH) _(—) ₀) (querytask 1106). If F₀>F_(TH) _(—) ₀, the fluid infusion device indicates anocclusion and initiates and executes appropriate corrective action (task1108), as described previously. For this example, the value of F_(TH)_(—) ₀ (4.0 pounds) is intentionally chosen to be much higher than anynormal operating actuation force and to be greater than the forcethreshold (F_(TH)) that is used during fluid delivery. The process 1100assumes that any measured force above F_(TH) _(—) ₀ is by definitioncaused by an occlusion and, therefore, the “Yes” branch of query task1106 leads directly to the task 1108 for immediate corrective action.

If F₀ is less than or equal to the initial force limit, then the process1100 determines the current force measurement and saves the value asF(i) (task 1110). The value of F(i) may be calculated in any desiredmanner. This particular example determines F(i) by averaging a number offorce measurements that are sampled while the drive motor assembly isstationary, e.g., immediately before or immediately after a deliverypulse. More specifically, the process 1100 may acquire ten forcereadings, discard the maximum and minimum readings, and compute theaverage of the remaining eight readings to arrive at F(i).

The process 1100 also determines a plurality of quantity measurementsduring the fluid delivery action, where each quantity measurement isdetermined relative to a reference quantity measurement, and where eachquantity measurement corresponds to a respective one of the forcemeasurements. For this embodiment, each quantity measurement representsor indicates a volume of fluid dispensed from the fluid reservoir,relative to a reference volume, a reference time, or any appropriatereference point or marker. In practice, the reference volume may bedefined to be any initial value (such as zero units) when a fluidreservoir is installed in the fluid infusion device, after completion ofa priming function for a newly installed fluid reservoir, immediatelyfollowing the completion of a fluid delivery operation, or the like.Thus, if the current fluid delivery operation is intended to deliver 0.5units and the reference volume is 0.0 units, then the recorded volumemeasurements should range between 0.0 units and 0.5 units. Referringagain to FIG. 16, the process 1100 determines the current deliveredvolume measurement and saves the value as U(i) (task 1112). Accordingly,each saved force measurement will have a corresponding saved volumemeasurement with the same index (i) value.

The process 1100 analyzes the force and volume measurements over twodifferent measurement windows, as described previously. Accordingly, theprocess 1100 must collect enough measurement points before determiningwhether an occlusion has occurred. In this regard, the process 1100 maycompare the current delivered volume measurement U(i) to thepredetermined small and large volume windows (task 1114). If U(i)<W_(SM)(which is 1.5 unit for this example), then the process 1100 may skip toa query task 1124. The process 1100 skips to query task 1124 at thistime because additional measurement points are needed before theintervening tasks can be properly executed.

If U(i)≧W_(LG) (which is 3.0 units for this example), then the process1100 assumes that enough measurement points have been collected, andcontinues by calculating a slope (rate of change) for a large sample ofvolume measurements (task 1116). In other words, the process calculatesa slope (S_(LG)) that is based on the large volume window. The value ofS_(LG) may be calculated using any suitable formula, algorithm,technique, or methodology. This particular example calculates S_(LG)based on the two “endpoints” of the large volume window. Morespecifically, S_(LG) is calculated based upon the current forcemeasurement F(i), the current volume measurement U(i), a previous forcemeasurement taken 3.0 units “in the past”, and a previous volumemeasurement taken 3.0 units “in the past”. Referring again to thescenario depicted in FIG. 15, the slope for the large window 1054 wouldbe computed based on the forces measured at 15.0 units and at 12.0units. The simple linear slope calculation employed by the process 1100disregards measurement points taken between the two endpoints. Alternateembodiments may, of course, consider any number of interveningmeasurement points if so desired.

The process 1100 may continue by comparing the calculated value ofS_(LG) to the stated value of S_(TH) _(—) _(LG) (which is 0.380 lb/U forthis example). If S_(LG)≧0.380 lb/U (the “Yes” branch of query task1118), then the process 1100 indicates an occlusion and initiates andexecutes appropriate corrective action (task 1108). In practice, thiscondition is indicative of a gradually increasing slope over arelatively large measurement window, even though a threshold actuationforce has not been reached. Accordingly, the fluid infusion device canstill generate an appropriate alarm without relying on a thresholdtrigger. If, however, S_(LG)<0.380 lb/U (the “No” branch of query task1118), then the process 1100 may continue by calculating a slope(S_(SM)) that is based on the small volume window (task 1120). It shouldbe appreciated that task 1120 need not be performed in response to thedetermination made during query task 1118. Indeed, task 1116 and task1120 could be performed in parallel and in an ongoing and dynamic mannerduring the fluid delivery operation regardless of the results of thevarious query tasks included in the process 1100.

Referring again to task 1120, the value of S_(SM) may be calculatedusing any suitable formula, algorithm, technique, or methodology. Thisparticular example calculates S_(SM) based on the two “endpoints” of thesmall volume window. More specifically, S_(SM) is calculated based uponF(i), U(i), an intervening force measurement taken 1.5 unit “in thepast”, and an intervening volume measurement taken 1.5 unit “in thepast”. The intervening force measurement and the intervening volumemeasurement are “intervening” in the sense that they correspond to astate of the fluid infusion device that occurred at a time between thecurrent state and the “previous” state, where the “previous” forcemeasurement and the “previous” volume measurement are associated withthe endpoint of the large measurement window as described above.Referring again to the scenario depicted in FIG. 15, the slope for thesmall window 1056 would be computed based on the forces measured at 15.0units and at 13.5 units.

The process 1100 may continue by comparing the calculated value ofS_(SM) to the stated value of S_(TH) _(—) _(SM) (which is 0.220 lb/U forthis example). For this example, the process 1100 indicates an occlusionwhen both: (a) S_(SM)≧0.220 lb/U; and (b) F(i)≧F_(TH) (the “Yes” branchof query task 1122). Indication of an occlusion at this time also causesthe process 1100 to initiate and execute appropriate corrective action(task 1108). In practice, this condition is indicative of an increasingslope over a relatively small measurement window, combined with theactuation force exceeding a stated threshold level (1.8 pounds for thisexample). Accordingly, the fluid infusion device can utilize a sensitiveslope criteria if the actuation force is already above a certainthreshold value. Moreover, the different sized measurement windows(small volume versus large volume, short delivery time versus longdelivery time, shorter piston travel versus longer piston travel, etc.)facilitate accurate occlusion detection while reducing the likelihood offalse alarms.

If S_(SM)<0.220 lb/U (the “No” branch of query task 1122), then theprocess 1100 may continue by checking whether more delivery strokes orpulses are needed for the current fluid delivery operation (query task1124). If there are no additional delivery strokes required, then theprocess 1100 ends. If more delivery stokes are required, then theprocess 1100 may begin or continue the programmed delivery stroke (task1126) to actuate the fluid reservoir by the desired amount. Inconnection with the next delivery stroke or pulse, the process 1100 mayperform another gross occlusion check (query task 1128). To this end,the process 1100 compares the current force measurement to the grossdelivery force limit (F_(TH) _(—) _(D)), which is 4.0 pounds for thisexample. If F>F_(TH) _(—) _(D), the fluid infusion device indicates anocclusion and initiates and executes appropriate corrective action (task1108), as described previously. Otherwise, the process 1100 incrementsthe index (i) at task 1130, and continues in the manner described above,beginning at task 1110. Thus, the process 1100 continues to monitor foran occlusion using both of the slope conditions, while updating andmoving the two measurement windows dynamically as the fluid reservoirdelivers additional fluid. The small and large volume windows employ thecurrent measurement point as one endpoint, and previous measurementpoints as the other endpoints (e.g., 1.5 unit in the past and 3.0 unitsin the past). These measurement windows dynamically shift as the fluidreservoir is actuated such that the fluid infusion device samples andprocesses the measurement points that fall within the boundaries of thewindows. Referring to FIG. 15, the measurement window would shift to theright as the fluid reservoir is actuated.

The occlusion detection techniques described above assume that actuationforce is the metric or measurement quantity used to determine whether ornot an occlusion in the fluid path has occurred. In such embodiments, aforce sensor is utilized to obtain the measurements. In alternateembodiments, the fluid infusion device may obtain and processmeasurements of any quantity (or quantities) that is indicative ofpressure in the fluid delivery path for purposes of occlusion detection.In this regard, actuation force associated with the fluid reservoir isan indirect way of measuring fluid pressure, where increasing fluidpressure is indicative of a potential occlusion.

Depending upon the particular implementation, the measured or detectedquantity might be associated with one or more of the following, withoutlimitation: reservoir actuation force (as described in detail above);fluid pressure in the fluid path of the device; a flow rate of fluid inthe fluid path, based on time, number of delivery strokes or pulses,etc.; electric current of the drive motor, which relates to the load onthe drive motor, which in turn relates to the fluid pressure in thereservoir; torque of the drive motor, which relates to the load on thedrive motor, which in turn relates to the fluid pressure in thereservoir; or the like. In practice, therefore, the fluid infusiondevice may obtain measurement information or data from one or moresources in lieu of or in addition to a force sensor. For example, theocclusion detection schemes presented above may process measurementsobtained from one or more of the following, without limitation: apressure sensor; a flow meter; a torque meter; an electrical circuitthat measures motor current; or any appropriate sensor, detector, orcircuit that is dynamically responsive to the fluid pressure in thefluid path or reservoir of the fluid infusion device.

While at least one exemplary embodiment has been presented in theforegoing detailed description, it should be appreciated that a vastnumber of variations exist. It should also be appreciated that theexemplary embodiment or embodiments described herein are not intended tolimit the scope, applicability, or configuration of the claimed subjectmatter in any way. Rather, the foregoing detailed description willprovide those skilled in the art with a convenient road map forimplementing the described embodiment or embodiments. It should beunderstood that various changes can be made in the function andarrangement of elements without departing from the scope defined by theclaims, which includes known equivalents and foreseeable equivalents atthe time of filing this patent application.

1.-14. (canceled)
 15. A method of detecting occlusions in a fluid pathof a fluid infusion device having a drive motor assembly that actuates apiston of a fluid reservoir to deliver fluid from the fluid reservoir,the method comprising: initiating a fluid delivery action to deliver anamount of fluid from the fluid reservoir; determining, for each of aplurality of measurement points associated with the fluid deliveryaction, a respective measurement of a quantity that is indicative ofpressure in the fluid path, along with a respective delivered volumemeasurement relative to a reference volume measurement; calculating afirst slope based upon a current measurement of the quantity, a previousmeasurement of the quantity, a current delivered volume measurementcorresponding to the current measurement of the quantity, and a previousdelivered volume measurement corresponding to the previous measurementof the quantity; calculating a second slope based upon the currentmeasurement of the quantity, an intervening measurement of the quantitythat is determined after determining the previous measurement of thequantity, the current delivered volume measurement, and an interveningdelivered volume measurement corresponding to the interveningmeasurement of the quantity; and indicating whether an occlusion hasoccurred by using the first slope and the second slope.
 16. The methodof claim 15, wherein the indicating step determines that the occlusionhas occurred when the first slope is greater than or equal to a firstthreshold slope value.
 17. The method of claim 16, wherein theindicating step determines that the occlusion has occurred when both:(a) the second slope is greater than or equal to a second thresholdslope value; and (b) the current measurement of the quantity is greaterthan or equal to a threshold value of the quantity.
 18. The method ofclaim 17, wherein the first threshold slope is greater than the secondthreshold slope.
 19. The method of claim 15, further comprising the stepof initiating corrective action for the fluid infusion device when theindicating step determines that the occlusion has occurred.
 20. Themethod of claim 15, wherein: the quantity is associated with anactuation force of the piston; and the determining step determines arespective force measurement for each of the plurality of measurementpoints. 21.-31. (canceled)
 32. A method of detecting occlusions in afluid path of a fluid infusion device having a drive motor assembly thatactuates a piston of a fluid reservoir to deliver fluid from the fluidreservoir, the method comprising: initiating a fluid delivery action todeliver an amount of fluid from the fluid reservoir; determining, foreach of a plurality of measurement points associated with the fluiddelivery action, a respective measurement of a quantity that isindicative of pressure in the fluid path, along with a respectivedelivered volume measurement relative to a reference volume measurement;comparing a current delivered volume measurement to a predeterminedlarge volume window measurement and a predetermined small volume windowmeasurement; if the current delivered volume measurement is greater thanthe predetermined large volume window measurement, calculating a firstslope based upon a current measurement of the quantity, a previousmeasurement of the quantity, the current delivered volume measurementcorresponding to the current measurement of the quantity, and a previousdelivered volume measurement corresponding to the previous measurementof the quantity; indicating an occlusion has occurred when the firstslope is greater than or equal to a first threshold slope value.
 33. Themethod of claim 32, wherein if the current delivered volume measurementis greater than the predetermined large volume window measurement, themethod further comprises: if the first slope is less than the firstthreshold slope value, calculating a second slope based upon the currentmeasurement of the quantity, an intervening measurement of the quantitythat is determined after determining the previous measurement of thequantity, the current delivered volume measurement, and an interveningdelivered volume measurement corresponding to the interveningmeasurement of the quantity; and indicating that an occlusion hasoccurred based on the second slope.
 34. The method of claim 33, whereinthe indicating step determines that the occlusion has occurred whenboth: (a) the second slope is greater than or equal to a secondthreshold slope value; and (b) the current measurement of the quantityis greater than or equal to a threshold value of the quantity.
 35. Themethod of claim 32, wherein if the current delivered volume measurementis less than the predetermined large volume window measurement butgreater than the predetermined small volume window measurement, themethod further comprises: calculating a second slope based upon thecurrent measurement of the quantity, an intervening measurement of thequantity that is determined after determining the previous measurementof the quantity, the current delivered volume measurement, and anintervening delivered volume measurement corresponding to theintervening measurement of the quantity; and indicating that anocclusion has occurred when both: (a) the second slope is greater thanor equal to a second threshold slope value; and (b) the currentmeasurement of the quantity is greater than or equal to a thresholdvalue of the quantity.
 36. The method of claim 32, wherein if thecurrent delivered volume measurement is less than the predeterminedsmall volume window measurement, the method further comprises:determining if additional fluid delivery actions are required to deliverthe amount of fluid from the fluid reservoir; if additional fluiddelivery strokes are needed, initiating a fluid delivery action; anddetermining if a current force measurement is greater than a grossdelivery force limit.
 37. The method of claim 32, wherein prior to thedetermining step, the method further comprises: determining an initialmeasurement of force that is indicative of initial pressure in the fluidpath; and indicating that an occlusion has occurred if the initialmeasurement of force is greater than an initial measurement of forcelimit.
 38. The method of claim 32, further comprising initiatingcorrective action for the fluid infusion device after indicating thatthe occlusion has occurred.
 39. The method of claim 32, wherein: thequantity is associated with an actuation force of the piston; and thedetermining step determines a respective force measurement for each ofthe plurality of measurement points.
 40. A method of detectingocclusions in a fluid path of a fluid infusion device having a drivemotor assembly that actuates a piston of a fluid reservoir to deliverfluid from the fluid reservoir, the method comprising: initiating afluid delivery action to deliver an amount of fluid from the fluidreservoir; determining an initial measurement of force that isindicative of initial pressure in the fluid path; if the initialmeasurement of force is less than or equal to an initial measurement offorce limit: determining, for each of a plurality of measurement pointsassociated with the fluid delivery action, a respective measurement of aforce that is indicative of an actuation force imparted to a forcesensor by the piston, along with a respective delivered volumemeasurement relative to a reference volume measurement; calculating afirst slope based upon a current measurement of force, a previousmeasurement of force, a current delivered volume measurementcorresponding to the current measurement of force, and a previousdelivered volume measurement corresponding to the previous measurementof force; calculating a second slope based upon the current measurementof force, an intervening measurement of force that is determined afterdetermining the previous measurement of force, the current deliveredvolume measurement, and an intervening delivered volume measurementcorresponding to the intervening measurement of force; and indicatingthat an occlusion has occurred based on the initial measurement offorce, the first slope and the second slope.
 41. The method of claim 40,wherein the indicating step determines that the occlusion has occurredwhen the initial measurement of force is greater than an initialmeasurement of force limit.
 42. The method of claim 40, wherein theindicating step determines that the occlusion has occurred when thefirst slope is greater than or equal to a first threshold slope value.43. The method of claim 40, wherein the indicating step determines thatthe occlusion has occurred when both: (a) the second slope is greaterthan or equal to a second threshold slope value; and (b) the currentmeasurement of force is greater than or equal to a threshold value offorce.
 44. The method of claim 40, further comprising initiatingcorrective action for the fluid infusion device after indicating thatthe occlusion has occurred.
 45. The method of claim 44, whereininitiating corrective action further comprises: generating an alert oralarm at the fluid infusion device.